Last updated: June 8, 2026

Sources for medical AI evaluation

These references anchor AI for Medical's evaluation framework and product profiles. Product claims are phrased from official vendor, documentation, regulatory, privacy, or company pages unless the profile says otherwise.

Governance and evaluation references

• FDA: Artificial Intelligence-Enabled Medical Devices
  Public list of AI-enabled medical devices authorized for marketing in the United States.
• FDA: Artificial Intelligence and Medical Products
  FDA landing page for AI across medical products and regulated centers.
• WHO: Ethics and governance of artificial intelligence for health
  Guidance emphasizing ethics, human rights, governance, accountability, and public benefit.
• NIST: AI Risk Management Framework
  Framework and playbook resources for AI risk management.
• AMA: Augmented intelligence in medicine
  AMA framing of AI as assistive technology that should enhance human intelligence rather than replace it.
• NIH News in Health: Artificial Intelligence and Your Health
  Patient-facing NIH explanation of promise and caution in health AI.

Product source index

Each product entry links back to its profile and the official source trail used for the current directory summary.

• OpenEvidence Clinical evidence and questions
  OpenEvidence describes itself as a medical information platform with JAMA and NEJM content agreements and clinician-focused evidence synthesis; its privacy materials describe HIPAA-aligned processing and state that AI models are not trained on PHI.
  www.openevidence.com / about · www.openevidence.com / policies / privacy · www.openevidence.com / announcements / openevidence-the-fastest-growing-application-for-physicians-in-history-announces-dollar210-million-round-at-dollar35-billion-valuation
• ClinicalKey AI Clinical evidence and questions
  Elsevier describes ClinicalKey AI as a generative AI clinical decision-support tool that grounds answers in evidence-based content and citations; product and support materials describe responsible-AI review, clinician-in-the-loop evaluation, HIPAA-compliant security posture, encryption, and limits on third-party AI partner access for training.
  www.elsevier.com / en-gb / products · www.elsevier.com / about / press-releases · www.elsevier.support / clinicalkeyai / answer · www.elsevier.support / clinicalkeyai / category
• UpToDate Expert AI Clinical evidence and questions
  Wolters Kluwer describes UpToDate Expert AI as an evidence-based GenAI clinical decision-support experience grounded in UpToDate content, with assumptions, source links, reasoning support, mobile access, and availability through select personal and enterprise subscriptions; terms emphasize clinician review and restrictions on personal data or PHI.
  www.wolterskluwer.com / en / solutions · www.wolterskluwer.com / en / solutions · www.wolterskluwer.com / en-ph / news
• Dyna AI Clinical evidence and questions
  EBSCO describes Dyna AI and Dyna AI Mode as AI experiences inside DynaMed, DynaMedex, and Dynamic Health that use retrieval from expert-curated evidence content, provide source links, preserve clinician control, and require human review; public terms restrict HIPAA-protected or similar medical data input into AI tools.
  more.ebsco.com / Dyna-AI.html · about.ebsco.com / news-center / press-releases · about.ebsco.com / health-care / clinical-decision-support · about.ebsco.com / clinical-decisions / dynamed-terms-of-use
• Glass Health Clinical evidence and questions
  Glass describes an AI-powered ambient scribing and clinical decision-support platform that listens during encounters, surfaces evolving differential diagnoses, suggests history questions and next steps, generates notes and plans, answers clinical reference questions with citations, supports EHR integration, and exposes a developer API for clinical queries, triage, record summarization, diagnostic support, treatment planning, documentation, and ambient scribing; its privacy policy covers prompts and outputs, and its clinician terms should be reviewed before entering patient context or relying on generated recommendations.
  glass.health · glass.health / features · glass.health / ambient-cds · glass.health / developer-api · glass.health / privacy · glass.health / tos · www.fda.gov / regulatory-information / search-fda-guidance-documents
• Consensus Clinical evidence and questions
  Consensus presents a medical research feature for clinical research and source-backed study snapshots, and its help materials explain source data and AI features such as study summaries and paper-level analysis.
  consensus.app / home / features · help.consensus.app / en / articles
• Elicit Clinical evidence and questions
  Elicit describes AI-enabled systematic reviews with search, screening, and data extraction workflows, and support materials distinguish systematic-review workflows from broader research-agent sourcing.
  docs.elicit.com · support.elicit.com / en / categories · bmcmedresmethodol.biomedcentral.com / articles / 10.1186
• Scite Clinical evidence and questions
  Research Solutions says Scite grounds AI-powered synthesis in verified citation statements and citation context through Scite Assistant.
  www.researchsolutions.com / scite · scite.org / assistant
• Atropos Health Clinical evidence and questions
  Atropos Health describes the Atropos Evidence Agent as a real-world evidence AI solution that can integrate into clinical workflows, and describes its evidence network as a federated data network for healthcare.
  www.atroposhealth.com / atropos-evidence-agent · www.atroposhealth.com / atropos-evidence-network · www.atroposhealth.com / chatrwd · www.atroposhealth.com / privacy-policy
• Doximity Ask Clinical evidence and questions
  Doximity's support page describes Doximity Ask as a HIPAA-compliant AI assistant for clinicians that can answer clinical questions with referenced responses, generate note templates, create patient education materials, translate content, and securely include PHI.
  www.doximity.com / doximity-gpt-info · support.doximity.com / hc / en-us · www.doximity.com / about / security
• Medwise AI Clinical evidence and questions
  Medwise AI presents itself as a UK medical information platform for healthcare professionals with modes for guidance, literature, web, drug, writing, and local search; its terms say outputs support human decisions, are not medical advice, and should be independently verified, while its privacy materials govern personal information handling.
  medwise.ai · medwise.ai / terms.html · medwise.ai / privacy.html · www.about.medwise.ai / news / introducing-medwise-organising-the-worlds-medical-knowledge
• AvoMD Clinical evidence and questions
  AvoMD describes a clinician-facing clinical decision support platform for care pathways, medical calculators, clinical algorithms, and AI-assisted workflows, with official materials emphasizing EHR integration, local content governance, and security review.
  www.avomd.com · www.avomd.com / providers · www.avomd.com / resources / ozarks-healthcare-partners-with-avo-to-integrate-ai-powered-decision-support-in-the-ehr · www.avomd.com / privacypolicy
• VisualDx Clinical evidence and questions
  VisualDx describes a visual clinical decision support system for diagnosis search, differential diagnosis, medical images, patient-centered explanations, API use, and DermExpert AI support; public pricing and legal materials describe subscription access, mobile requirements, image-analysis availability, and privacy terms.
  www.visualdx.com · www.visualdx.com / solutions / clinical-decision-support · www.visualdx.com / solutions / derm-expert · www.visualdx.com / pricing · www.visualdx.com / legal / privacy-policy
• Isabel DDx Companion Clinical evidence and questions
  Isabel describes DDx Companion as a machine-learning differential diagnosis generator covering more than 10,000 conditions, all ages, and specialties; its Active Intelligence materials describe NLP extraction of clinical features from EMR documentation, and product pages describe evidence-based reference links plus Cerner and Epic workflow options.
  www.isabelhealthcare.com · isabelhealthcare.com / products / isabel-ddx-companion · www.isabelhealthcare.com / products / active-intelligence
• Causaly Clinical evidence and questions
  Causaly describes an agentic AI platform for life-sciences R&D with scientific agents, precision evidence retrieval, biomedical knowledge graphs, private-data workflows, and governed evidence-backed outputs for discovery and development teams.
  www.causaly.com · www.causaly.com / products / agentic-research · www.causaly.com / products / discover · www.causaly.com / legal / privacy-policy · www.causaly.com / news / causaly-introduces-first-agentic-ai-platform-built-for-life-sciences-research-and-development
• AMBOSS AI Mode Clinical evidence and questions
  AMBOSS describes AI Mode as a clinician-designed AI search agent for clinical care that connects natural-language questions to verified AMBOSS medical knowledge and selected external sources; AMBOSS also describes AI Mode Learning as a study copilot inside its education platform, and its privacy policy covers personal-data processing for the AMBOSS website, registered program, apps, and institutional licenses.
  www.amboss.com / int / clinical-ai-mode · www.amboss.com / us / newsroom · www.amboss.com / us / newsroom · www.amboss.com / us / privacy
• Abridge Clinical documentation and scribes
  Abridge describes ambient clinical documentation with provenance and clinician review, and publishes separate privacy and trust-center materials for due diligence.
  www.abridge.com / ai · www.abridge.com / privacy · trust.abridge.com
• Ambience Healthcare Clinical documentation and scribes
  Ambience presents a broader clinical workflow platform spanning ambient scribing, chart support, coding-ready notes, and EHR-connected pre-, in-, and post-visit workflows, with separate privacy statements for data handling.
  www.ambiencehealthcare.com / products · www.ambiencehealthcare.com / privacy · www.ambiencehealthcare.com / clinicians
• Nuance DAX Copilot Clinical documentation and scribes
  Microsoft and Nuance position DAX Copilot as ambient clinical documentation built on Azure, Dragon, and clinician review workflows, with marketplace materials highlighting HITRUST-CSF certification and mobile/EHR note creation.
  appsource.microsoft.com / en-us / product · www.microsoft.com / en-us / industry
• Microsoft Dragon Copilot Clinical documentation and scribes
  Microsoft describes Dragon Copilot as an extensible AI clinical assistant and workspace for streamlining documentation, surfacing information, automating tasks, integrating with EHRs and PowerScribe workflows, and supporting role-based physician, nurse, and radiology experiences.
  www.microsoft.com / en-us / health-solutions · learn.microsoft.com / en-us / industry · news.microsoft.com / source / 2025
• Oracle Health Clinical AI Agent Clinical documentation and scribes
  Oracle describes Clinical AI Agent as a unified AI workflow layer for clinical, administrative, patient, and financial workflows, with chart review documentation that can answer care-related questions and provide AI-generated summaries from EHR sources.
  www.oracle.com / health / clinical-suite · docs.oracle.com / en / industries · www.oracle.com / health / clinical-suite
• AWS HealthScribe Clinical documentation and scribes
  AWS describes HealthScribe as a HIPAA-eligible ML capability for healthcare software vendors that transcribes patient-clinician conversations, generates preliminary clinical notes, supports batch and streaming workflows, maps generated note text back to transcript evidence, and requires trained medical professional review before patient-care use.
  aws.amazon.com / healthscribe · docs.aws.amazon.com / transcribe / latest · docs.aws.amazon.com / ai / responsible-ai
• DeepScribe Clinical documentation and scribes
  DeepScribe describes an AI medical scribe that captures natural clinician-patient conversations, produces structured notes for review and EHR sync, supports specialty workflows, SmartPrep pre-visit chart synthesis, AI coding, and customization; public integration and platform materials describe bidirectional EHR integration, HIPAA compliance claims, AES-256 encryption, de-identified PHI, MFA, limited user access, and single sign-on.
  www.deepscribe.ai / solutions / ai-medical-scribe · www.deepscribe.ai / platform / ai-clinical-documentation-software · www.deepscribe.ai / solutions / smartprep · www.deepscribe.ai / solutions / ai-coding · www.deepscribe.ai / ehr-integrations · trust.deepscribe.ai
• Suki Clinical documentation and scribes
  Suki describes ambient documentation, assisted revenue cycle, clinical reasoning, and Q&A in one assistant.
  www.suki.ai · www.suki.ai / press-releases / suki-launches-patient-summarization-and-clinical-qa-for-doctors-with-google-cloud
• Nabla Clinical documentation and scribes
  Nabla presents an ambient AI assistant for note generation across care settings and publishes separate security materials describing cloud controls, certifications, and regional data-hosting choices.
  www.nabla.com · www.nabla.com / security · help.nabla.com / en / articles
• Freed Clinical documentation and scribes
  Freed presents itself as an AI scribe and assistant for creating SOAP notes.
  www.getfreed.ai · try.getfreed.ai
• Heidi Health Clinical documentation and scribes
  Heidi describes a platform for qualified medical practitioners, including Heidi Scribe for AI-powered clinical documentation, Heidi Evidence for literature support, and Heidi Comms for voice interactions.
  www.heidihealth.com · www.heidihealth.com / en-us / legal · www.heidihealth.com / safety
• ModMed Scribe Clinical documentation and scribes
  ModMed describes Scribe 2.0 as an ambient AI documentation solution built into EMA EHR that suggests structured notes, billing codes, and downstream clinical workflow actions for specialty practices.
  www.modmed.com / solutions / ai · www.modmed.com / resources / home · www.modmed.com / press-release / modmed-unveils-dermatology-specific-ai-with-modmed-scribe
• Augmedix Clinical documentation and scribes
  Augmedix describes ambient documentation products for clinician workflows, including AI-powered and human-assisted offerings that draft notes and support EHR-connected documentation.
  augmedix.com · augmedix.com / products / augmedix-go · augmedix.com / products / augmedix-live · augmedix.com / privacy-policy
• Commure Ambient AI Clinical documentation and scribes
  Commure describes Ambient AI as clinical documentation software that captures the clinical interaction, structures documentation, supports care cues, macros, clinician-assistant tasks, and downstream revenue workflows inside existing EHR environments; public privacy materials describe HIPAA-oriented handling where applicable.
  www.commure.com / ambient-ai · docs.ambient.commure.com / get_started / overview · www.commure.com / legal / privacy-policy · www.commure.com
• Tali AI Clinical documentation and scribes
  Tali describes an AI Ambient Scribe and AI Medical Dictation product, with public pricing, FAQ, privacy, and security materials that discuss HIPAA, PHIPA, SOC 2 Type II, data residency options, audio handling, and clinician documentation workflows.
  tali.ai / us · tali.ai / us / pricing · tali.ai / faq · tali.ai / privacy-policy · sales.tali.ai / tali-ai-security-privacy-overview
• Twofold Health Clinical documentation and scribes
  Twofold describes an AI medical scribe for clinicians that records clinical sessions and generates structured notes; help-center materials describe HIPAA compliance, BAA availability, privacy controls, and intended use as clinician documentation support.
  www.trytwofold.com · help.trytwofold.com / en / articles · help.trytwofold.com / en / articles
• Nabla Copilot Clinical documentation and scribes
  Nabla describes an ambient AI, dictation, and real-time intelligence assistant for clinical documentation, with web, mobile, Chrome extension, API, and EHR-embedded deployment options; public security and help materials describe HIPAA/GDPR posture, SOC 2 Type II and ISO 27001 certifications, no audio storage by default, configurable medical-data retention, and no model training on customer data.
  www.nabla.com · www.nabla.com / connect · www.nabla.com / security · help.nabla.com / en / articles · trust.nabla.com
• Eleos Health Clinical documentation and scribes
  Eleos describes a behavioral health AI platform for documentation, compliance, and care operations; product, FAQ, and security materials describe narrative note support, ambient or text-summary input, compliance review, U.S.-based AWS hosting, HIPAA/SOC 2/HITRUST/ISO controls, short audio retention, and behavioral-health-specific model development.
  eleos.health · eleos.health / ai-frequently-asked-questions · eleos.health / compliance · eleos.health / security · eleos.health / resources
• TORTUS Clinical documentation and scribes
  TORTUS describes an AI medical scribe for NHS clinicians and publishes compliance and privacy materials discussing DTAC assurance, UK GDPR, encrypted browser audio capture, UK-based cloud processing, notes, codes, and clinician documentation workflows.
  tortus.ai · tortus.ai / compliance · tortus.ai / privacy-notice
• NextGen Clinical AI Clinical documentation and scribes
  NextGen describes Clinical AI as ambient listening that transcribes patient visits, generates structured SOAP notes, creates patient summaries, and suggests ICD-10s, medications, labs, imaging, orders, and macros inside NextGen Mobile and EHR workflows; company AI and trust pages describe HIPAA-oriented privacy and security controls, while a product release describes expanded Ambient Assist and an Office version for small practices.
  www.nextgen.com / solutions / provider-experience · www.nextgen.com / artificial-intelligence · www.nextgen.com / company / newsroom · www.nextgen.com / trust
• Aidoc Medical imaging and radiology
  Aidoc describes radiology AI that helps prioritize findings, streamline workflows, activate care teams, and run through an aiOS platform; its FAQ and security pages point buyers to product-specific 510(k) notices, quality-system compliance, and cloud security review.
  www.aidoc.com / solutions / radiology · www.aidoc.com / platform / aios · www.aidoc.com / learn / faq · www.aidoc.com / about / security-privacy
• AIRS Medical SwiftMR Medical imaging and radiology
  AIRS Medical describes SwiftMR as FDA-cleared AI MRI enhancement software that can reduce scan time by up to 50% in the United States, restore diagnostic quality on accelerated scans, and operate alongside OEM deep-learning reconstruction workflows; FDA 510(k) summaries describe DICOM MRI image enhancement using convolutional neural-network filtering, while AIRS privacy materials discuss HIPAA/BAA handling and limited PHI and DICOM image storage for product functionality.
  airsmed.com / en / swiftmr · airsmed.com / en / swiftmr-oemdl · airsmed.com / en / fda-510k-2022 · www.accessdata.fda.gov / cdrh_docs / pdf21 · www.accessdata.fda.gov / cdrh_docs / pdf22 · www.accessdata.fda.gov / cdrh_docs / pdf23 · airsmed.com / en / privacy-policy-us
• Viz.ai Medical imaging and radiology
  Viz.ai states its platform is driven by more than 50 FDA-cleared algorithms and supports imaging-driven care coordination; its trust center frames security and privacy diligence for clinical-data deployments.
  www.viz.ai · www.viz.ai / privacy-policy · www.viz.ai / trust-center · www.viz.ai / news / viz-ai-announces-successful-completion-of-soc-2-type-ii-hipaa-audits-for-viz-ai-one-platform
• Ferrum Health Medical imaging and radiology
  Ferrum Health describes an AI Governance Suite that connects to existing infrastructure, deploys and monitors clinical AI models, supports model hubs for FDA-cleared, CE-marked, open-source, and homegrown tools, and publishes privacy and FAQ materials covering data protection and PHI handling.
  www.ferrumhealth.com · www.ferrumhealth.com / platform-and-tech · www.ferrumhealth.com / privacy-policy · ferrumhealth.com / faqs
• Blackford Platform Medical imaging and radiology
  Blackford describes an enterprise AI platform for integrating, routing, deploying, and monitoring multiple medical imaging AI applications, with a curated marketplace and privacy/security materials that emphasize platform-level controls while leaving each application to be evaluated separately.
  blackfordanalysis.com / platform · blackfordanalysis.com / data-privacy-and-security · blackfordanalysis.com / hitrust-certification · blackfordanalysis.com / resources / introducing-curated-marketplace
• CARPL.ai Medical imaging and radiology
  CARPL describes a radiology AI marketplace and enterprise imaging platform with access to hundreds of AI applications, PACS-connected orchestration, validation, deployment, and monitoring capabilities; FDA records list K232891 for CARPL as a web-based PACS and radiology workflow management device for viewing and assessing DICOM images, while CARPL's privacy policy describes collection and processing of personal details and medical-condition images.
  carpl.ai · carpl.ai / ai-marketplace · carpl.ai / news / carplai-receives-us-fda-clearance-to-make-clinical-ai-deployment-safer · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf23 · carpl.ai / privacy-policy
• deepcOS Medical imaging and radiology
  deepc describes deepcOS as a radiology AI operating system that supports access to multiple AI solutions, workflow integration, evaluation on local data, orchestration, monitoring, and one-contract deployment; official CIO and security materials describe ISO 27001:2022, C5, HIPAA/GDPR positioning, encryption, pseudonymization, and short retention claims.
  www.deepc.ai / deepcos-for / healthcare-management · www.deepc.ai / deepcos-for / chief-information-officers · www.deepc.ai / news / deepc-becomes-the-first-radiology-ai-platform-to-be-certified-under-new-information-security-standard-iso-27001-2022
• Enlitic Curie / ENDEX Medical imaging and radiology
  Enlitic describes Curie as an AI-powered platform for healthcare data quality, with ENDEX using NLP and computer vision to normalize medical imaging study and series descriptions and ENCOG removing PHI from DICOM metadata, private tags, and burned-in pixel data while retaining clinically relevant information; company materials also describe GE HealthCare collaboration around Curie-powered data standardization in radiology workflows.
  enlitic.com / data-quality-management · ir.enlitic.com / our-products · enlitic.com / press / curie_release · enlitic.com / press / data-standardization · enlitic.com / wp-content / uploads · enlitic.com / privacy-policy
• Brainomix 360 Stroke Medical imaging and radiology
  Brainomix describes Brainomix 360 Stroke as an FDA-cleared and CE-marked collection of stroke imaging tools; company FDA-clearance announcements cover e-ASPECTS and non-contrast CT core-volume assessment, while Brainomix patient-data materials describe temporary server processing, pseudonymized cloud access in some workflows, and hospital-directed retention.
  www.brainomix.com / stroke · www.brainomix.com / news / brainomix-receives-fda-clearance-for-its-flagship-stroke-ai-imaging-software · www.brainomix.com / news / core-volume-fda-clearance · www.brainomix.com / processing-patient-and-other-data · www.accessdata.fda.gov / cdrh_docs / pdf23
• Avicenna.AI CINA-ASPECTS Medical imaging and radiology
  Avicenna.AI describes CINA-ASPECTS as a neurovascular imaging tool that analyzes non-enhanced head CT to calculate ASPECTS, provide heat maps, and support stroke severity assessment; FDA materials list 510(k) K233342 for CINA-ASPECTS and state it is not intended for primary CT interpretation, with validation and use limits around known MCA or ICA occlusion, adult patients over 21, specific scanner manufacturers, and acute brain ischemia within 12 hours from last known well.
  avicenna.ai / solutions / head · avicenna.ai / fda-clearances-aspects-and-ipe · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf23 · avicenna.ai / resources / clinical-publications · avicenna.ai / privacy-policy
• Qure.ai Medical imaging and radiology
  Qure.ai describes medical imaging AI for tuberculosis, lung cancer, stroke, and other care pathways; its regulatory and privacy page lists product-specific U.S. FDA 510(k) clearances, CE certifications, ISO 27001 status, de-identification, and deployment-security controls.
  www.qure.ai · documentation.qure.ai · www.qure.ai / regulatory-and-privacy · www.qure.ai / privacy-policy
• Qure.ai qXR Medical imaging and radiology
  Qure.ai describes qXR as chest X-ray AI for pre-read assistance, overlays, reporting support, abnormality detection across chest anatomy, and cloud or on-premise deployment; Qure's regulatory page lists several qXR-related FDA 510(k) clearances, and FDA materials for qXR-PTX-PE describe adult chest X-ray triage for suspected pleural effusion or pneumothorax that is not intended for standalone clinical decision-making.
  www.qure.ai / product / qxr · www.qure.ai / regulatory-and-privacy · www.accessdata.fda.gov / cdrh_docs / pdf23 · www.qure.ai / privacy-policy
• Oxipit ChestLink Medical imaging and radiology
  Oxipit describes ChestLink as a CE Class IIb autonomous AI imaging application for chest X-ray analysis that reports high-confidence studies with no abnormalities; Oxipit materials outline retrospective, supervised, and autonomous deployment phases, while Sectra announced and completed its acquisition of Oxipit in 2026. Oxipit's privacy notice is a website notice, so clinical data-processing terms should be checked contractually.
  oxipit.ai · oxipit.ai / article / autonomous-ai-medical-imaging-understanding-chestlink · oxipit.ai / news / first-autonomous-ai-medical-imaging-application · oxipit.ai / privacy-policy · medical.sectra.com / news-press-releases / news-item
• Rad AI Medical imaging and radiology
  Rad AI describes Reporting as generative AI radiology reporting software that works with existing microphones, PACS, RIS, EHR systems, templates, and free-dictation styles, while Impressions auto-generates radiologist-style impressions. The company says radiologists review and sign final reports, its security page describes SOC 2 Type II HIPAA+ certification and radiology-report de-identification, and its reporting-platform privacy policy says de-identified findings and generated reports are stored by the service.
  www.radai.com / reporting · www.radai.com / impressions · www.radai.com · www.radai.com / security · app.reportrad.ai / privacy
• Rad AI Continuity Medical imaging and radiology
  Rad AI describes Continuity as follow-up management software that identifies and categorizes recommendations from radiology reports, automates provider or patient communication when clinically appropriate, integrates with EHR/RIS workflows, and maintains dashboards and audit trails; the company security page describes SOC 2 Type II HIPAA+ certification and radiology-report de-identification.
  www.radai.com / continuity · www.radai.com · www.radai.com / security
• Sirona RadOS Medical imaging and radiology
  Sirona describes RadOS as a cloud-native radiology platform that unifies PACS, viewer, worklist, reporting, DICOM, HL7, speech, and AI-powered workflow automation. Its product pages state that radiologists keep control of report content, that pixel-to-report is a prospective feature under regulatory review, and that the reporting component is managed with medical-device rigor; the public privacy notice is website-focused, so clinical data-processing and BAA terms require contract review.
  sironamedical.com · sironamedical.com / reporting · sironamedical.com / privacy-policy · www.prnewswire.com / news-releases / sirona-medical-announces-launch-of-sironas-rados-platform-at-2021-radiological-society-of-north-america-rsna-annual-meeting-301433833.html
• Bayer Calantic Digital Solutions Medical imaging and radiology
  Bayer describes Calantic as a cloud-hosted radiology AI platform that gives radiologists access to a curated portfolio of applications for worklist prioritization, detection, quantification, and disease-area service lines through a PACS-integrated viewer. Bayer launch materials position it as a vendor-neutral platform for AI-enabled medical imaging applications, while subscription materials should be reviewed for security, licensing, medical-advice disclaimers, and customer data-processing obligations.
  www.calantic.com · www.calantic.com / en-us / about-us · www.bayer.com / media / en-us · www.radiologysolutions.bayer.com / files / Radimetrics-OC-Terms-and-Conditions.pdf
• Cleerly Medical imaging and radiology
  Cleerly describes AI-enabled CCTA coronary plaque analysis for comprehensive and trackable insights; its indications page says Cleerly Labs is Rx-only software for trained medical professionals and should not replace qualified practitioner judgment.
  cleerlyhealth.com / plaque-analysis · cleerlyhealth.com / indications-for-use · cleerlyhealth.com / providers · cleerlyhealth.com / ischemia-reinvented · cleerlyhealth.com / privacy-policy
• Elucid PlaqueIQ Medical imaging and radiology
  Elucid describes PlaqueIQ as FDA-cleared non-invasive plaque analysis based on CCTA and objective histology; FDA materials list PlaqueIQ image-analysis software, while Elucid privacy materials describe PHI handling, remote access, confidentiality, and security controls for medical image processing services.
  elucid.com · elucid.com / elucid-receives-u-s-510k-clearance-of-plaqueiq-image-analysis-software-to-aid-cardiovascular-disease-assessment · www.accessdata.fda.gov / cdrh_docs / pdf24 · elucid.com / instructions-for-use · elucid.com / privacy-policy
• LumineticsCore Medical imaging and radiology
  Digital Diagnostics describes LumineticsCore as an autonomous AI diagnostic system for more-than-mild diabetic retinopathy in adults with diabetes, with FDA De Novo clearance, device-specific indications, contraindications, warnings, camera requirements, and point-of-care workflow controls.
  www.digitaldiagnostics.com / products / eye-disease · www.digitaldiagnostics.com / products / eye-disease · www.digitaldiagnostics.com / newsroom / fda-permits-marketing-of-lumineticscore-formerly-known-as-idx-dr-for-automated-detection-of-diabetic-retinopathy-in-primary-care · www.digitaldiagnostics.com / privacy-policy
• Eyenuk EyeArt Medical imaging and radiology
  Eyenuk describes EyeArt as an FDA-cleared autonomous AI eye-screening system for more-than-mild and vision-threatening diabetic retinopathy; FDA records list EyeArt K200667 and EyeArt v2.2.0 K223357 as diabetic-retinopathy detection devices, while Eyenuk materials describe supported cameras, cloud workflow, security, and privacy contacts.
  www.eyenuk.com / us-en / products · www.eyenuk.com / us-en / articles · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh · www.eyenuk.com / en / privacy-policy
• AEYE-DS Medical imaging and radiology
  AEYE Health describes AEYE-DS as an FDA-cleared autonomous diabetic-retinopathy screening system for one non-mydriatic image per eye using supported Topcon NW400 and Optomed Aurora cameras; FDA records list AEYE-DS K221183 and K240058, and AEYE privacy materials describe retinal-image, exam-identifier, MRN, and diagnostic-result processing.
  www.aeyehealth.com / aeye-diagnostic-screening · www.aeyehealth.com / privacy-policy · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf24
• RETINA-AI Galaxy Medical imaging and radiology
  RETINA-AI states that Galaxy is FDA-cleared for autonomous detection of moderate-or-worse diabetic retinopathy and lists indications, supported CenterVue DRSPlus, Crystalvue NFC-700, and Topcon NW400 cameras, contraindications, warnings, and HIPAA compliance claims.
  www.retinahealth.ai · www.retinahealth.ai / regulatory · www.retinahealth.ai / privacy-policy
• RetInSight Fluid Monitor Medical imaging and radiology
  RetInSight describes Fluid Monitor as software for nAMD that automatically visualizes and quantifies IRF, SRF, and PED on OCT, produces follow-up charts, and meets MDR 2017/745 Class IIa medical-device requirements; company materials describe CE marking for an AI-based clinical decision-support system.
  www.retinsight.com / ai-in-clinical-routine / fluid-monitor · www.retinsight.com / news / retinsight-fluid-monitor-provides-next-evolutionary-step-in-monitoring-of-neovascular-age-related-macular-degeneration · www.retinsight.com
• RetinAI Discovery Medical imaging and radiology
  RetinAI describes Discovery as a vendor-neutral ophthalmology image and data platform with AI enrichment, Discovery for clinics and clinical studies, GDPR/HIPAA/PIPEDA privacy claims, CE-marked Discovery and AI modules, FDA-cleared Discovery platform status, and U.S. research-use-only limits for several AI modules.
  www.retinai.com / products / discovery · www.retinai.com · www.retinai.com / about-us · www.retinai.com / privacy-policy · www.retinai.com / data-processing-agreement
• RapidAI Medical imaging and radiology
  RapidAI describes a clinical AI and enterprise imaging platform, including stroke, vascular, hemorrhage, and aortic workflows; its materials describe FDA-cleared modules, edge/cloud deployment choices, Data Privacy Framework terms, and healthcare security certifications.
  www.rapidai.com · www.rapidai.com / platform · www.rapidai.com / press-release / rapidai-extends-the-reach-of-deep-clinical-ai-with-five-new-fda-clearances · www.rapidai.com / press-release / ncct-stroke · www.rapidai.com / it · www.rapidai.com / privacy-policy
• Heartflow Medical imaging and radiology
  Heartflow describes AI-powered non-invasive heart-care analysis for coronary CTA, including FFRCT, plaque, and roadmap analysis; company materials include FDA clearance history and a 2025 next-generation plaque-analysis clearance announcement.
  www.heartflow.com / about · www.heartflow.com / indications · www.heartflow.com / press-release / Heartflow-plaque-analysis-and-roadmap-analysis-fda-510k-clearance · ir.heartflow.com / node / 6481 · www.heartflow.com / wp-content / uploads · www.heartflow.com / press-release / nextgen-plaque-analysis
• Caristo CaRi-Plaque and CaRi-Heart Medical imaging and radiology
  Caristo describes CaRi-Heart as an AI solution that quantifies coronary inflammation and characterizes plaque from routine CCTA, with secure anonymized transfer and regulatory clearance in the UK, Europe, and Australia; the Caristo site states CaRi-Heart is limited to investigational use in the United States, while FDA records list CaRi-Plaque 510(k) K242240 as a cleared radiological image-processing system for coronary plaque and stenosis analysis.
  www.caristo.com / cari-heart-technology · www.caristo.com / coronary-plaque-analysis · www.accessdata.fda.gov / scripts / cdrh · www.caristo.com / wp-content / uploads · www.caristo.com / wp-content / uploads
• Ultromics EchoGo Medical imaging and radiology
  Ultromics describes EchoGo Heart Failure as an FDA-cleared AI-enabled medical device and diagnostic aid for HFpEF detection from echocardiography; FDA records list EchoGo Heart Failure 510(k) clearances, and Ultromics privacy materials describe customer-controlled patient-data processing and EchoGo retention terms.
  www.ultromics.com / products / echogo-heart-failure · www.ultromics.com / press-releases / ultromics-receives-fda-clearance-for-its-breakthrough-device-echogo-heart-failure · www.accessdata.fda.gov / cdrh_docs / pdf24 · www.ultromics.com / privacy-notice
• Us2.ai Medical imaging and radiology
  Us2.ai describes an FDA-cleared automated echocardiography platform for DICOM-based measurements, disease-detection support, and structured reports; product, regulatory, integration, and security materials describe multi-market clearances, PACS/CVIS/reporting integration, regional data residency or on-premises deployment options, and enterprise compliance claims.
  us2.ai · us2.ai / product · us2.ai / resources / regulatory-status · us2.ai / operations / integrations · us2.ai / terms-conditions · us2.ai / security
• Gleamer BoneView Medical imaging and radiology
  Gleamer describes BoneView as an AI second-reader for trauma bone X-rays, with workflow integrations, worklist support, and clinical-study references; its regulatory page states that BoneView US is FDA-cleared under K222176 and explains personal-data processing for imaging users.
  www.gleamer.ai / us / copilot · www.gleamer.ai / us / copilot · www.gleamer.ai / privacy-policy · www.accessdata.fda.gov / cdrh_docs / pdf22
• iCAD ProFound AI Medical imaging and radiology
  iCAD describes ProFound breast-health AI for 2D and 3D mammography detection, density, scorecard, and risk-related workflows; its product and FDA-clearance materials distinguish cleared detection products from risk features that require product-specific status review.
  www.icadmed.com / breast-health · www.icadmed.com / profound-detection-v4-0 · www.icadmed.com / about / news-events · www.icadmed.com / wp-content / uploads
• GI Genius Medical imaging and radiology
  Medtronic describes GI Genius as an AI-powered, first-to-market computer-aided polyp detection system for colonoscopy; the product labeling says it is adjunctive, does not diagnose, does not replace clinical decision-making or histopathology, and is limited to standard white-light endoscopy. FDA De Novo materials classify GI Genius as a prescription computer-assisted detection device.
  www.medtronic.com / en-us / healthcare-professionals · news.medtronic.com / 2021-04-12-U-S-FDA-Grants-De-Novo-Clearance-for-First-and-Only-Artificial-Intelligence-System-for-Colonoscopy-Medtronic-Launches-GI-Genius-TM-Intelligent-Endoscopy-Module · www.accessdata.fda.gov / cdrh_docs / reviews · www.medtronic.com / content / dam
• SKOUT Medical imaging and radiology
  Iterative Health describes SKOUT as real-time AI for polyp detection; its indications page states that SKOUT is a computer-aided detection tool for adult screening or surveillance colonoscopy, is limited to white-light colonoscopy, and does not replace medical judgment or make resection decisions. FDA 510(k) materials list SKOUT as a gastrointestinal lesion software detection system.
  iterative.health / products / skout · iterative.health / indications-warnings-and-risks · iterative.health / latest-news / blog · www.accessdata.fda.gov / cdrh_docs / pdf23
• Fujifilm CAD EYE Medical imaging and radiology
  Fujifilm describes CAD EYE as AI deep-learning technology for real-time detection of colonic mucosal lesions during colonoscopy; Fujifilm announced U.S. 510(k) clearance and commercialization for CAD EYE, while FDA summary materials identify EW10-EC02 as gastrointestinal lesion software detection support for colonoscopic images.
  healthcaresolutions-us.fujifilm.com / products / endoscopy · www.fujifilm.com / us / en · www.fujifilm.com / us / en · www.accessdata.fda.gov / cdrh_docs / pdf23
• Olympus CADDIE Medical imaging and radiology
  Olympus describes CADDIE as medical device software in the OLYSENSE platform that analyzes endoscopic video in real time to assist gastroenterologists in detecting suspected colorectal polyps. FDA records list CADDIE as a gastrointestinal lesion software detection system, and Olympus materials distinguish U.S. detection support from broader regional OLYSENSE CAD/AI portfolios.
  medical.olympusamerica.com / products / caddie · medical.olympusamerica.com / articles / first-cloud-based-ai-endoscopy-system-colonoscopy-receives-fda-clearance · medical.olympusamerica.com / articles / olympus-launches-olysense%E2%84%A2-platform-cadeai-solution-us · medical.olympusamerica.com / articles / eagle-trial-shows-olympus%C2%AE-caddie%E2%84%A2-ai-solution-aids-detection-high-risk-and-hard-detect · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf24
• MammoScreen Medical imaging and radiology
  MammoScreen describes a 2D and 3D FDA-cleared breast cancer screening AI solution with pre-check, priors, pre-reporting, and scoring workflows; Therapixel and FDA materials list MammoScreen clearances including K192854, K243679, K241561, and K243685 for detection or breast-density software.
  www.mammoscreen.com · www.mammoscreen.com / faq · www.mammoscreen.com / mammoscreen-fda-cleared-available-for-sale-us · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh
• Kheiron Mia Medical imaging and radiology
  Kheiron describes Mia as a breast screening AI platform with Mia Triage for double-reading triage and Mia IQ for image-quality assurance; product pages state CE/UK status for Mia, TGA and Medsafe clearance for Mia, and FDA registration for Mia IQ in the United States.
  www.kheironmed.com / products / mia-triage · www.kheironmed.com / products / mia-iq-tm · www.kheironmed.com / solutions · www.kheironmed.com / kheirons-ai-breast-screening-solution-mia-receives-regulatory-clearance-in-australia-and-new-zealand · www.rcr.ac.uk / our-services / artificial-intelligence-ai
• ScreenPoint Transpara Medical imaging and radiology
  ScreenPoint describes Transpara as a breast AI suite for detection, density, and temporal-comparison workflows and states that Transpara is CE marked and FDA cleared for 2D and 3D mammography; FDA records list Transpara 2.1.0 under K241831 and Transpara Density under K232096.
  screenpoint-medical.com · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf23
• Koios DS Breast Medical imaging and radiology
  Koios describes Koios DS Breast as FDA-cleared and CE-marked smart ultrasound software for breast cancer risk assessment; FDA K212616 materials describe Koios DS as an AI/ML CADx adjunct for diagnostic ultrasound examinations of suspicious breast lesions and thyroid nodules.
  koiosmedical.com / products / koios-ds-breast · koiosmedical.com / products · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf21
• Subtle Medical Medical imaging and radiology
  Subtle Medical describes AI tools for MRI and PET image quality and acceleration, including SubtleMR, SubtlePET, and the Subtle-ELITE MRI package; company announcements and FDA 510(k) documents should be checked for product-specific clearance and indication details.
  subtlemedical.com · subtlemedical.com / subtlemr · subtlemedical.com / subtlepet · subtlemedical.com / policy · subtlemedical.com / subtle-medicals-subtlehd-wins-fda-clearance-setting-a-new-benchmark-for-mri-image-quality-and-speed · www.accessdata.fda.gov / cdrh_docs / pdf19
• Lunit Medical imaging and radiology
  Lunit describes a cancer AI ecosystem spanning screening, diagnosis, treatment decisions, and drug development, including Lunit INSIGHT radiology products and Lunit SCOPE precision-oncology and pathology products; FDA-listed records and Lunit regulatory pages should be checked for product-specific status.
  www.lunit.io / en · www.lunit.io / en / technology · www.fda.gov / medical-devices / software-medical-device-samd
• annalise.ai Medical imaging and radiology
  annalise.ai describes radiology AI products for chest X-ray and non-contrast head CT, including Annalise Enterprise, Annalise Triage, FDA-cleared U.S. findings, CE-marked regional products, worklist prioritization, and draft reporting support.
  annalise.ai · annalise.ai / annalise-triage · annalise.ai / annalise-enterprise-ctb · annalise.ai / 2023 / 11
• CureMetrix Medical imaging and radiology
  CureMetrix describes FDA-cleared cmTriage for mammography worklist triage and separate cmAssist CAD materials; the FDA 510(k) database lists cmTriage as radiological computer-assisted prioritization software for lesions under K183285.
  curemetrix.com / solution-summary · curemetrix.com / cm-triage-3 · www.accessdata.fda.gov / scripts / cdrh
• Hologic Genius AI Detection Medical imaging and radiology
  Hologic describes Genius AI Detection as deep-learning software for breast tomosynthesis lesion detection, and FDA records list Hologic Genius AI Detection 2.0 clearances including K221449, K230096, and K243341 under radiological computer assisted detection or diagnosis software.
  www.hologic.com / geniusai-detection-part2 · investors.hologic.com / press-releases / press-release-details · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf24
• GE HealthCare Caption AI Medical imaging and radiology
  GE HealthCare describes Caption Guidance as AI-driven software on the Venue family that helps users capture diagnostic-quality cardiac images, and FDA records list Caption Interpretation Automated Ejection Fraction Software as an AI-enabled radiology device.
  www.gehealthcare.com / products / ultrasound · gehealthcare-ultrasound.com / en / venue-family · www.gehealthcare.com / en-us / about · www.fda.gov / medical-devices / software-medical-device-samd
• Butterfly iQ3 Medical imaging and radiology
  Butterfly describes Butterfly iQ3 as an FDA-cleared handheld point-of-care ultrasound system and announced FDA clearance for a blind-sweep gestational-age AI tool; FDA's AI-enabled device list also includes Butterfly iQ3.
  www.butterflynetwork.com · www.butterflynetwork.com / press-releases / fda-clearance-butterfly-iq3 · ir.butterflynetwork.com / News / press-releases · www.fda.gov / medical-devices / software-medical-device-samd
• Sonio Detect Medical imaging and radiology
  Sonio describes Sonio Detect as an FDA 510(k)-cleared AI product for real-time fetal ultrasound view detection, anatomical-structure detection, and quality-criteria verification; FDA 510(k) summaries for K230365, K240406, and K252433 describe concurrent-reading-aid indications and version-specific validation and compatibility details.
  sonio.ai / products · sonio.ai / news / fda-clearance · sonio.ai / artificial-intelligence · www.accessdata.fda.gov / cdrh_docs / pdf23 · www.accessdata.fda.gov / cdrh_docs / pdf24 · www.accessdata.fda.gov / cdrh_docs / pdf25 · www.fda.gov / medical-devices / software-medical-device-samd
• DeepHealth Breast Suite Medical imaging and radiology
  DeepHealth describes Breast Suite as a modular AI-powered breast imaging suite; its product page notes FDA 510(k) clearance K251873 for Saige-Dx while also labeling some modules as pending clearance or not cleared for U.S. use. FDA summaries for Saige-Dx describe concurrent reading-aid use for qualified interpreting physicians reviewing screening DBT mammograms with compatible hardware.
  deephealth.com / population-health / breast-suite · deephealth.com / press-releases / radnets-deephealth-expands-fda-clearance-for-smartmammo-solution · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf25 · www.accessdata.fda.gov / cdrh_docs / pdf24 · deep.health / privacy-policy
• Pearl Second Opinion Medical imaging and radiology
  Pearl describes Second Opinion as real-time dental radiology AI for detecting dental conditions in X-rays, while 2025 company materials state FDA 510(k) clearance for Second Opinion 3D and data-protection materials describe privacy controls for dental practices.
  www.hellopearl.com / products / second-opinion · hellopearl.com / news / pearl-becomes-first-dental-ai-company-cleared-by-fda-for-both-2d-and-3d-imaging · www.hellopearl.com / legal / privacy-policy · www.hellopearl.com / legal / data-protection · www.accessdata.fda.gov / cdrh_docs / pdf21
• Overjet Medical imaging and radiology
  Overjet describes an FDA-cleared dental AI suite for radiograph analysis, decay detection, bone-level measurement, image enhancement, and workflow automation; public materials also include HIPAA, privacy, BAA, and FDA-clearance announcements.
  www.overjet.com / solutions / dental-ai-software · www.overjet.com / blog / overjet-receives-second-fda-clearance-adding-overjet-caries-assist-to-the-industry-s-1-dental-ai-platform · www.overjet.com / blog / overjet-earns-fda-clearance-to-enhance-dental-images-with-ai · www.overjet.com / privacy-policy · www.overjet.com / hipaa-policy · www.overjet.com / baa
• VideaAI Medical imaging and radiology
  Videa describes Clinical Assist as dental AI that analyzes X-rays in real time and highlights FDA-cleared conditions, while its 2024 FDA-clearance announcement says Videa Dental AI includes more than 30 algorithms and pediatric caries detection for ages three and older.
  www.videa.ai / clinical-assist · videa.ai / news / videa-dental-assist-clearance · www.videa.ai / privacy-policy · www.videa.ai / terms-of-service
• Denti.AI Medical imaging and radiology
  Denti.AI describes Detect and Auto-Chart for dental X-ray analysis, condition highlighting, and charting automation, with FDA-cleared imaging claims and Health Canada licensing; FDA records list Denti.AI Auto-Chart K222054 and Denti.AI Detect K230144, while Denti.AI privacy and terms pages describe personal data, voice data, retention, transfers, and product-service boundaries.
  www.denti.ai · www.denti.ai / about · www.denti.ai / privacy-policy · www.denti.ai / terms-of-use · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh
• Diagnocat Medical imaging and radiology
  Diagnocat describes FDA-cleared dental image-processing, 3D visualization, radiological reports, and HIPAA/SOC 2-aligned product claims; FDA K252934 lists Diagnocat as a CADe second-read tool for periapical radiolucency on previously acquired maxillofacial CBCT scans of permanent teeth in adults.
  diagnocat.com / us · diagnocat.com / us / products · diagnocat.com / files / privacy-policy-diagnocat.pdf · legal.diagnocat.com / terms / en · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf25
• DentalMonitoring Medical imaging and radiology
  DentalMonitoring describes an AI-powered orthodontic Software as a Medical Device for remote treatment monitoring, with FDA De Novo approval and MDR certification claims; FDA DEN230035 lists DentalMonitoring, and DentalMonitoring privacy materials describe personal-data processing for its remote-care services.
  dentalmonitoring.com · dentalmonitoring.com / privacy-policy · www.accessdata.fda.gov / scripts / cdrh · www.businesswire.com / news / home · www.businesswire.com / news / home
• DermaSensor Medical imaging and radiology
  DermaSensor describes an FDA-cleared AI-powered skin cancer risk detection device for physicians that uses elastic scattering spectroscopy and returns Monitor or Investigate Further outputs; FDA's De Novo summary for DEN230008 states the device is an adjunctive second-read tool for suspicious lesions and is not standalone diagnosis, screening, biopsy replacement, or clinical-decision replacement.
  www.dermasensor.com / skin-cancer-detection-device · www.accessdata.fda.gov / cdrh_docs / reviews · www.dermasensor.com / faq · www.dermasensor.com / privacy-policy
• Skin Analytics DERM Medical imaging and radiology
  Skin Analytics states that DERM is a Class III CE-marked AI as a Medical Device for skin cancer, has been deployed across NHS pathways, and publishes post-market performance, certifications, clinical evidence, and information-security materials; its site also notes U.S. investigational-device limitations.
  skin-analytics.com / ai-pathways / derm-performance · skin-analytics.com / ai-pathways / certifications · skin-analytics.com / faq · skin-analytics.com / privacy-policy
• FotoFinder Moleanalyzer pro Medical imaging and radiology
  FotoFinder describes Moleanalyzer pro as dermoscopy software for analysis, comparison, second opinion, and AI support; its instructions for use describe a CNN-based AI Score, online and offline scoring options, image-transfer requirements, and warnings that the AI Score is statistical support for doctors and not guaranteed.
  www.fotofinder-systems.com / products / fotofinder-ai · www.fotofinder.com / fileadmin / Documentation · www.fotofinder-systems.com / products / hub-cloud-solutions
• DermEngine Medical imaging and radiology
  DermEngine describes an AI-powered dermatology platform for capturing and analyzing images of skin, hair, and nails, with image archiving, management, visual search, automated mole matching, evolution tracking, patient portal, and clinic analytics features.
  www.dermengine.com · www.dermengine.com / molescope · www.dermengine.com / dermoscopy · www.dermengine.com / privacy
• Model Dermatol Medical imaging and radiology
  Model Dermatology describes Model Dermatol as an AI dermatology image-search tool for finding relevant skin disease information, states that it is freely available on Android, iOS, and PCs, and says it should not be used as a medical device for diagnosis. Its privacy policy says submitted cropped images and metadata are transferred for analysis but not stored, and the site states the algorithm has CE MDR Class I marking but no FDA approval.
  modelderm.com · modelderm.com / setup.html · modelderm.com / index.php / privacy-policy-3
• SkinVision Patient access, triage, and agents
  SkinVision describes a CE-certified EU MDR Class IIa medical device app that uses AI and dermatologist oversight to provide low or high risk indications for skin spots; help materials state that Smart Check is trained and validated by dermatologists, supports melanoma, BCC, SCC, and actinic keratosis risk assessment, and provides guidance rather than diagnosis.
  www.skinvision.com · www.skinvision.com / press-release / skinvision-earns-europes-top-medical-certification-for-ai-powered-skin-cancer-detection · skinvision.zendesk.com / hc / en-us · www.skinvision.com / privacy
• Paige Digital pathology
  Paige describes AI applications for cancer pathology and a prostate suite for detection and diagnosis support.
  www.paige.ai · info.paige.ai / prostate
• PathAI Digital pathology
  PathAI says AISight powers digital pathology workflows and AI applications; AISight Dx materials describe FDA-cleared primary-diagnosis image management with specified scanner support, while other AI algorithms and research workflows require separate intended-use review.
  www.pathai.com / aisight · www.pathai.com / aisightdx-digital-pathology-solution · www.pathai.com / news / pathai-receives-fda-clearance-for-aisight-dx-platform-for-primary-diagnosis · www.accessdata.fda.gov / cdrh_docs / reviews
• Hologic Genius Digital Diagnostics Digital pathology
  Hologic describes Genius Digital Diagnostics as a digital cytology system with the Genius Cervical AI algorithm, and FDA records list the system under De Novo DEN210035 and device listings; FDA recall records should also be checked for review-station component actions before deployment.
  www.hologic.com / hologic-products / cytology · investor.hologic.com / press-releases / press-release-details · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scrIpts / cdrh · www.accessdata.fda.gov / scripts / cdrh
• Ibex Medical Analytics Digital pathology
  Ibex describes an AI-powered pathology platform for automated insights across cancer workflows, structured reporting partnerships, regulatory distinctions by solution and region, a U.S. 510(k)-cleared Galen Second Read prostate workflow, and published privacy and compliance materials.
  ibex-ai.com / solutions · ibex-ai.com / technology · ibex-ai.com / fda-510k-clearance · ibex-ai.com / trust-center / compliance · ibex-ai.com / privacy-policy · ibex-ai.com / mtuitiveta-reporting-pr
• Deep Bio DeepDx Prostate Digital pathology
  Deep Bio describes DeepDx Prostate as clinically validated, CE-marked, Korea MFDS-approved AI diagnostic-support software for prostate cancer H&E slides, with cloud and on-premise deployment options, Gleason-pattern overlays, quantification features, and published validation references; its product materials also state that DeepDx solutions are not FDA-cleared and are research-use-only in the United States.
  deepbio.co.kr / products / prostate-cnb · deepbio.co.kr / products · indicalab.com / news / press-release-deep-bio-successfully-integrates-deepdx-prostate-algorithm-into-halo-ap-platform-from-indica-labs · www.fda.gov / medical-devices / 510k-clearances
• Proscia Digital pathology
  Proscia describes Concentriq as an enterprise pathology platform for digital pathology, AI applications, data science, diagnostics, and life-sciences workflows; Concentriq AP-Dx materials describe FDA 510(k) clearance for primary diagnosis with a specified scanner, while other platform and AI components may have research-use limits.
  proscia.com / concentriq-platform · proscia.com / concentriq-ap-dx · proscia.com / ai · proscia.com / concentriq-dx · proscia.com / press-releases / proscia-receives-fda-510k-clearance-for-concentriq-ap-dx-2 · proscia.com / wp-content / uploads
• Aiforia Digital pathology
  Aiforia describes clinical pathology suites for whole-slide image analysis and notes that only certain clinical AI models and the Clinical Suite Viewer are CE-IVD marked for diagnostic use in the EU and EEA, with other markets limited to research or performance-study use.
  www.aiforia.com / aiforia-clinical-suite · www.aiforia.com / breast-cancer-ai · www.aiforia.com / prostate-cancer-ai · www.aiforia.com / press-releases / aiforia-releases-a-new-ce-ivd-marked-ai-solution-for-gastric-cancer-diagnostics · www.aiforia.com / privacy-policy · www.aiforia.com / about-us
• Mindpeak Digital pathology
  Mindpeak says it offers AI-powered pathology suites for diagnostic labs, including breast IHC scoring, PD-L1, HER2, prostate, onychomycosis, lymphocyte quantification, and peakDissect workflows, and states recognition including ISO 13485 certification and multiple CE-IVD products; its privacy policy provides website-level data-processing context that is separate from customer deployment terms.
  www.mindpeak.ai · www.mindpeak.ai / for-diagnostic-labs · www.mindpeak.ai / privacy-policy · www.mindpeak.ai / news / mindpeak-announces-first-ce-marked-fully-automated-software-to-support-breast-cancer-tissue-diagnosis
• Aignostics Digital pathology
  Aignostics describes Atlas H&E-TME as a research-use tumor microenvironment profiling product powered by a histopathology foundation model, with broad cancer coverage, quantitative metrics, validation documents, GDPR and ISO 27001 statements, and an explicit not-for-diagnostic-use limitation.
  www.aignostics.com / products / atlas-he-tme · www.aignostics.com · www.aignostics.com / company / about
• Lumea Digital pathology
  Lumea describes an integrated digital pathology workflow spanning tissue handling, Viewer+, BxLink, AI partner integrations, molecular testing, and specialty workflows; its public materials say Viewer+ is FDA-cleared for primary clinical diagnosis with whole-slide images while BxLink is not approved by FDA for digital primary diagnosis.
  lumeadigital.com · lumeadigital.com / pathology · lumeadigital.com / bxlink · lumeadigital.com / fda-cleared-digital-pathology-viewer · lumeadigital.com / privacy-policy
• Visiopharm Digital pathology
  Visiopharm describes AI-driven precision pathology software for research and diagnostics, including IVDR-certified CE-IVD diagnostic APPs, research image-analysis tools, and integration workflows with image-management systems; its privacy policy describes customer and website data processing separately from deployment-specific diligence.
  visiopharm.com · visiopharm.com / diagnostics-pathology-image-analysis-software · visiopharm.com / press-releases / visiopharm-products-now-ivdr-certified · visiopharm.com / press-releases / visiopharms-precision-pathology-apps-to-be-integrated-with-pathais-aisight-image-management-system · visiopharm.com / privacypolicy
• Tribun Health Digital pathology
  Tribun Health describes CaloPix as a web-based image-management system for managing, visualizing, and analyzing whole-slide images, with AI app integration, telepathology, archiving, and scanner/LIS interoperability; its legal notice states regional regulatory status and separate AI Module Terms of Use.
  www.tribun.health / calopix-1 · www.tribun.health / homepage · www.tribun.health / about · www.tribun.health / legal-notice
• Roche navify Digital Pathology Digital pathology
  Roche describes navify Digital Pathology as enterprise pathology software for case workflow, multi-slide viewing, annotation, collaboration, cloud or on-prem deployment, scanner interoperability, PACS and navify Pathology Lab Hub integration, and access to AI-based image analysis algorithms through Roche Open Environment. Roche labeling materials describe Roche Digital Pathology Dx as an aid for qualified pathologists reviewing FFPE whole-slide images and state limits for other applications, while FDA records list Roche Digital Pathology Dx 510(k) clearances K232879 and K242783.
  diagnostics.roche.com / us / en · diagnostics.roche.com / us / en · diagnostics.roche.com / us / en · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh · navify.roche.com / gr / en-us
• PathPresenter Digital pathology
  PathPresenter describes an enterprise image-management and workflow platform for digital pathology, clinical care, remote consultations, research, education, biorepository management, and AI model access; its public materials state that the Clinical Viewer received FDA 510(k) clearance for primary diagnosis only with specified Hamamatsu scanner files and a Barco display configuration.
  www.pathpresenter.com · www.pathpresenter.com / clinical-care · www.pathpresenter.com / research · www.pathpresenter.com / fda-510k-clearance · www.accessdata.fda.gov / scripts / cdrh · www.pathpresenter.com / about-pathpresenter · www.pathpresenter.com / terms · www.pathpresenter.com / privacy-policy
• DoMore Diagnostics Histotype Px Colorectal Digital pathology
  DoMore Diagnostics describes Histotype Px Colorectal as a CE-IVD-marked deep-learning digital biomarker for stage II and III colorectal cancer prognosis using routine H&E slides, with published and ongoing validation work and integrations or partnerships with digital pathology platforms including PathAI, Sectra, Proscia, and Paige.
  www.domorediagnostics.com / products · www.domorediagnostics.com / news / do-more-diagnostics-achieves-ce-mark-43lh6 · www.domorediagnostics.com / news / domore-diagnostics-pathai-partnership · www.domorediagnostics.com / news / domore-esmo25
• Regard Clinical operations and revenue cycle
  Regard describes an AI-powered platform that generates documentation and surfaces critical insights in patient history, and its mobile privacy policy frames the Scribe App as a HIPAA business-associate workflow for recording encounters, transcripts, and note merging.
  regard.com · regard.com / privacy-policy-mobile · regard.com / press / regard-to-improve-patient-care-and-unlock-revenue-at-scale-through-microsoft-dragon-copilot-collaboration
• Bayesian Health Clinical operations and revenue cycle
  Bayesian Health describes a real-time clinical intelligence platform that reads EHR signals, adapts to patient baselines, surfaces risk, guides clinicians inside workflows, and reports published and real-world outcome claims; FDA records list K250680 for the Bayesian Health Sepsis Flagging Device as a Class II software device to aid sepsis prediction or diagnosis.
  www.bayesianhealth.com · www.bayesianhealth.com / platform · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf25 · www.prnewswire.com / news-releases / bayesian-health-receives-first-ever-fda-clearance-for-continuous-ai-sepsis-monitoring-302769190.html · www.bayesianhealth.com / privacymfs · www.bayesianhealth.com / wp-content / uploads
• CLEW ICU Clinical operations and revenue cycle
  CLEW describes CLEW ICU as an AI-driven clinical surveillance platform for high-acuity care with FDA-cleared class II predictive models; FDA records list K233216 for the CLEWICU System as a medium-term adjunctive predictive cardiovascular indicator with a January 13, 2024 substantial-equivalence decision.
  clewmed.com / our-solution / clew-icu · clewmed.com / technology · clewmed.com / clew-medical-secures-fda-clearance-for-second-generation-ai-models · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf23 · clewmed.com / privacy
• Mednition KATE Clinical operations and revenue cycle
  Mednition describes KATE as a clinical AI platform for emergency department triage, sepsis recognition, and clinical analytics that reads structured and unstructured EHR data; company materials describe KATE Sepsis as having FDA Breakthrough Device Designation, while FDA guidance explains that designation is not the same as marketing authorization.
  mednition.com / products · mednition.com / kate-artificial-intelligence-designed-for-clinicians-by-clinicians · mednition.com / fda-grants-kate-ai-breakthrough-device-designation-for-early-sepsis-detection · mednition.com / customer-data-privacy-policy · mednition.com / patient-safety-improvement-umass-memorial · www.fda.gov / medical-devices / how-study-and-market-your-device
• Fathom Clinical operations and revenue cycle
  Fathom describes medical coding AI for autonomous coding workflows, publishes automation and accuracy claims, and has announced HITRUST i1 certification for data protection and privacy controls.
  www.fathomhealth.com · www.fathomhealth.com / insights / the-difference-between-medical-coding-automation-and-computer-assisted-coding · www.fathomhealth.com / insights / fathom-advances-data-protection-and-privacy-in-autonomous-medical-coding-with-hitrust-i1-certification
• CodaMetrix Clinical operations and revenue cycle
  CodaMetrix says it provides an AI-powered contextual coding automation platform for medical coding quality and performance, with CMX CARE materials describing longitudinal clinical context, payer-rule support, and coding across service lines.
  www.codametrix.com · www.codametrix.com / our-solution · www.codametrix.com / resources / codametrixs-ai-platform-now-available-in-epic-toolbox-to-transform-20b-medical-coding-sector
• Apicare AuthAdvisor Clinical operations and revenue cycle
  Apixio materials describe Apicare AuthAdvisor as AI-powered prior authorization decision support that analyzes historical administrative and decision data, can approve requests in seconds, exposes user-controlled thresholds by procedure, and routes requests needing review; Datavant privacy materials describe HIPAA business-associate safeguards for PHI handled on behalf of healthcare customers, while CMS prior authorization rules frame payer obligations for interoperability, decision data, and process transparency.
  insight.apixio.com / prior-authorization · insight.apixio.com / frost-sullivan-2022-technology-innovation-leadership-award · www.datavant.com / privacy-policy · www.datavant.com / about / privacy-compliance · www.cms.gov / newsroom / fact-sheets
• Nym Clinical operations and revenue cycle
  Nym describes a Clinical Language Understanding and rules-based autonomous coding engine for multispecialty revenue-cycle workflows, with public materials emphasizing zero-human-intervention coding, transparent audit trails, Epic Toolbox designation, and SOC 2/HITRUST-mapped and HIPAA assessment claims.
  nym.health · nym.health / autonomous-medical-coding / nym-engine · nym.health / autonomous-medical-coding / the-technology · www.businesswire.com / news / home
• SmarterDx Clinical operations and revenue cycle
  SmarterDx describes proprietary clinical AI for hospital revenue integrity that analyzes patient charts to find documentation, diagnosis, charge, and denials opportunities, and notes that customer-data processing is governed by enterprise agreements rather than the public website privacy policy.
  www.smarterdx.com · www.smarterdx.com / smarter-by-design · www.smarterdx.com / legal / privacy · www.smarterdx.com / resources / smarter-technologies-launches-the-industrys-first-ai-powered-revenue-management-automation-and-insights-platform
• Waystar AltitudeAI Clinical operations and revenue cycle
  Waystar describes an AI-powered revenue cycle platform with AltitudeAI across financial clearance, patient financial care, clinical integrity, claims, denials, and analytics, and its CDI materials describe AI-supported documentation specificity, gaps, coding opportunities, and EHR workflow integration.
  www.waystar.com · www.waystar.com / our-platform / clinical-integrity-revenue-capture · www.waystar.com / news / iodine-software-launches-appeals-management-workspace-supporting-denials-management-alongside-genai-platform-enhancements
• Cedar Intelligence Clinical operations and revenue cycle
  Cedar describes Cedar Intelligence as an AI-powered personalization engine for patient financial engagement, bill explanations, agent guidance, and Kora outbound voice workflows; current product pages emphasize healthcare-specific billing data, privacy/security-aware design, and operational metrics that should be validated locally.
  www.cedar.com / solutions / cedar-intelligence · www.cedar.com · www.cedar.com / all-press / cedar-expands-ai-powered-personalization-in-healthcare-billing-with-new-cedar-intelligence-capabilities · pages.cedar.com / hubfs / Content%20Assets
• Carta Healthcare Voyager Clinical operations and revenue cycle
  Carta Healthcare describes Voyager as an AI platform for clinical data abstraction with FHIR access, supporting evidence, data provenance, human validation, AWS Bedrock hosting, customer data isolation, SOC 2 audits, HIPAA BAAs, and no customer-data training of external models.
  www.carta.healthcare / clinical-data-management / ai-platform · www.carta.healthcare / clinical-data-management · www.carta.healthcare / clinical-data-management / clinical-data-abstraction · www.carta.healthcare
• Layer Health Clinical operations and revenue cycle
  Layer Health describes an enterprise LLM platform for healthcare chart review that reasons across longitudinal patient charts for registry automation, custom quality measurement, and clinical pathways; public resources describe health-system collaborations for clinical registry reporting, while the privacy policy says customer data is governed by business-customer agreements rather than the website policy.
  www.layerhealth.com · www.layerhealth.com / health-systems · www.layerhealth.com / resources / layer-health-johns-hopkins-medicine · www.layerhealth.com / company · www.layerhealth.com / privacy
• Wellsheet Care Team Copilot Clinical operations and revenue cycle
  Wellsheet describes Care Team Copilot as an AI platform that unites chart summarization, documentation, and clinical pathways; product pages describe machine-learning prioritization, EHR/payer-system integration, handoff, smart alerts, discharge planning, and automated risk calculators, while company materials describe LLM-generated handoff summaries and Smart EHR UI workflows.
  www.wellsheet.com · www.wellsheet.com / product · www.wellsheet.com / ai-powered-smart-ehr-ui-delivers-usability-and-roi · www.wellsheet.com / post / why-ai-for-healthcare-needs-a-smart-ehr-ui
• Tennr Clinical operations and revenue cycle
  Tennr describes an agentic patient orchestration platform for policy-grade patient flow, including document extraction, service-to-criteria mapping, intelligent triage, workflow orchestration, communications coordination, and quality-controlled autopilot; its privacy policy says health data is processed for provider customers under customer agreements and HIPAA privacy and security standards.
  www.tennr.com / product · www.tennr.com · www.tennr.com / about · www.tennr.com / privacy
• AKASA Clinical operations and revenue cycle
  AKASA describes healthcare-specific generative AI for revenue cycle workflows including prebill optimization, coding, CDI, authorization status, and claim status, and platform materials describe integrations, reporting, experts, and HIPAA-aligned security certifications.
  akasa.com · akasa.com / platform · akasa.com / generative-ai-in-healthcare-revenue-cycle · akasa.com / wp-content / uploads
• Forus Clinical operations and revenue cycle
  Forus says it automates medication access workflows including prior authorizations, appeal letters, enrollment forms, benefit verification, specialty pharmacy calls, PA renewals, affordability programs, and patient communication; its public materials state that it works with major EHRs and references HIPAA, BAA, SOC 2 Type II, encryption, and US-based enterprise systems.
  forus.com · forus.com / pp · security.forus.com
• Case Health AI Clinical operations and revenue cycle
  Case Health AI describes integrated AI agents for health-plan prior authorization that handle intake, compare provider documentation against criteria, determine approval, denial, or outreach routing, and return case details to utilization management systems; its privacy policy says it acts as a HIPAA business associate and uses encryption, RBAC, audit logs, and client-owned data controls.
  www.casehealth.ai · www.casehealth.ai / legal / privacy-policy
• Notable Clinical operations and revenue cycle
  Notable describes a healthcare AI platform for automation across patient access, care delivery, quality, risk, revenue cycle, and administrative burden reduction, with privacy materials noting that customer-service data is governed by separate customer agreements.
  www.notablehealth.com / index.html · www.notablehealth.com / solutions / patient-access · www.notablehealth.com / privacy-policy · www.notablehealth.com / ai-platform / overview
• Qventus Clinical operations and revenue cycle
  Qventus describes an operations automation platform using real-time data, AI, machine learning, behavioral science, and EHR integration, with AI Operational Assistants for administrative tasks across hospital care settings.
  www.qventus.com / solutions / healthcare-automation-platform · www.qventus.com / solutions / ai-operational-assistants · www.qventus.com
• Caremaze Clinical operations and revenue cycle
  Caremaze describes an AI-powered discharge orchestration layer that ingests EMR data, analyzes charts for likely barriers, proposes tasks for staff approval, coordinates work across care teams, and deploys Voice AI agents for routine outreach; its security page describes HIPAA business associate status, SOC 2 Type II, ISO 27001, encryption, U.S. data residency, tenant isolation, and AI governance documentation.
  www.caremaze.com · www.caremaze.com / security
• Laudio Clinical operations and revenue cycle
  Laudio describes an AI-enhanced leader operations platform for health systems that centralizes frontline leader workflows, aggregates data from source systems, surfaces AI-driven recommendations, supports employee engagement and patient rounding, and says the platform is AWS-hosted and SOC 2 Type II compliant.
  laudio.com · laudio.com / about-us · laudio.com / faq
• LeanTaaS iQueue Clinical operations and revenue cycle
  LeanTaaS describes iQueue as a cloud-based healthcare capacity-management suite using artificial intelligence, machine learning, predictive analytics, and prescriptive recommendations for operating rooms, infusion centers, and inpatient flow; public privacy materials say some customer-directed personal information is handled under customer agreements rather than the website policy.
  leantaas.com / products · iqueue.com / products / operating-rooms · iqueue.com / products / infusion-centers · iqueue.com / products / inpatient-flow · surgical-clinics.leantaas.com / privacy-policy
• Iodine AwareCDI Clinical operations and revenue cycle
  Iodine describes AwareCDI as an AI-powered clinical documentation integrity suite that continuously analyzes clinical notes to flag documentation gaps or inconsistencies; its privacy policy states that services can involve PHI under customer business associate agreements.
  iodinesoftware.com / solutions / clinical-documentation-integrity · iodinesoftware.com / newsroom / iodine-software-unveils-awarecdi · iodinesoftware.com / privacy-policy
• Cohere Health Clinical operations and revenue cycle
  Cohere Health describes a clinical intelligence platform for AI-powered prior authorization, utilization management, payment integrity, and Cohere Unify workflows; its privacy policy says PHI on the password-restricted platform is governed by customer BAAs and that sensitive information is protected in transit and at rest.
  www.coherehealth.com · www.coherehealth.com / platform · www.coherehealth.com / guiding-principles-of-ai · coherehealth.com / privacy-policy
• Xsolis Dragonfly Clinical operations and revenue cycle
  Xsolis describes Dragonfly as an AI-powered platform for utilization management, case management, revenue cycle, and payer-provider collaboration, with real-time clinical data, medical-necessity insights, generative summaries, and human-in-the-loop workflows.
  www.xsolis.com · www.xsolis.com / solutions / utilize · www.xsolis.com / solutions · www.xsolis.com / press-release / xsolis-announces-dragonfly-at-xchange-24 · www.xsolis.com / privacy-policy
• Navina Clinical operations and revenue cycle
  Navina describes a clinician-first AI copilot for value-based care that reconciles EHR, HIE, claims, care-gap, and document data into evidence-linked patient insights, HCC recommendations, documentation support, quality workflows, and analytics; Navina also reports SOC 2 Type II plus HIPAA audit completion.
  www.navina.ai · www.navina.ai / core-technology · www.navina.ai / products / chart-review · www.navina.ai / news / successful-soc-2-type-ii-hipaa-audit · www.navina.ai / white-papers / phyx-2025-independent-study-on-navina
• Artisight Clinical operations and revenue cycle
  Artisight describes a smart hospital platform using edge computing, AI-powered automation, ambient intelligence, cameras, microphones, RTLS tags, EHR integration, virtual nursing, patient safety, predictive analytics, and smart-room workflows.
  artisight.com · artisight.com / smart-hospital-technology · artisight.com / patient-room · artisight.com / privacy-policy
• care.ai Clinical operations and revenue cycle
  care.ai describes a Smart Care Facility Platform with AI-assisted virtual nursing, smart patient rooms, ambient sensors, command-center awareness, predictive analytics, patient or protocol monitoring, and Stryker-owned smart-room technology.
  www.care.ai · www.care.ai / smart-hospital.html · www.care.ai / sensors.html · www.care.ai / stryker-acquires-care-ai.html
• AvaSure Intelligent Virtual Care Clinical operations and revenue cycle
  AvaSure describes an intelligent virtual care platform for virtual nursing, continuous observation, virtual sitting, AI-enabled applications, computer-vision and machine-learning workflows, in-room devices, real-time analytics, EHR and nurse-call integrations, privacy controls, and secure deployment options.
  avasure.com / platform · avasure.com / virtual-nursing · avasure.com / virtual-sitting · avasure.com / patient-safety-observation · avasure.com / technology-operations
• Caregility Connected Care Clinical operations and revenue cycle
  Caregility describes Connected Care as a virtual care platform with clinical applications, smart-room devices, integrations, security controls, virtual nursing workflows, iObserver one-to-many observation, and optional AI capabilities such as augmented observation, voice commands, and radar-based vitals trending.
  caregility.com / caregility-cloud-virtual-care-platform · caregility.com / caregility-cloud-virtual-care-platform / ai-capabilities · caregility.com / telehealth-programs / virtual-nursing · caregility.com / caregility-cloud-virtual-care-platform / applications
• Oxehealth Oxevision Clinical operations and revenue cycle
  Oxehealth training materials describe Oxevision as a contact-free, camera-based system for ward safety that provides alerts, readings, reports, and limited live video views; FDA records list Oxevision Sleep Device K233618 as a substantially equivalent neurology device, while Oxehealth IFU materials separate regulated Vital Signs software from Activity Tracker CDSS features.
  www.oxehealth.academy / modules / what-is-oxevision · www.oxehealth.academy / modules / what-does-oxevision-do · www.oxehealth.academy / instructions-for-use · www.accessdata.fda.gov / scripts / cdrh · assets.website-files.com / 5f5678688f40811eed0fe944 / 62c3096344b6063ba7806edb_Oxehealth%20-%20Privacy%20Notice%20-%20Customer%20v6.pdf
• Cadence Clinical Intelligence Clinical operations and revenue cycle
  Cadence describes itself as a clinical AI company for chronic care that tracks vitals, symptoms, medications, and engagement, uses AI agents with safety guardrails, and keeps physicians in control; its terms describe remote physiological monitoring, chronic care management, advanced primary care management, telehealth services, and connected devices.
  www.cadence.care · www.cadence.care / terms-of-service · www.cadence.care / privacy-policy · www.cadence.care / post / cadence-launches-ai-powered-proactive-care-engine-bringing-advanced-primary-care-management-to-medicare-patients-nationwide
• Biofourmis Biovitals Clinical operations and revenue cycle
  Biofourmis describes a platform for care delivery and life sciences that connects medical-grade devices, remote data collection, data science, and advanced analytics; company materials state that Biovitals uses AI-driven models of personalized vitals baselines and that the Biovitals Analytics Engine received FDA clearance for ambulatory physiologic monitoring.
  biofourmis.com / platform · biofourmis.com / news-insights / biofourmis-biovitals-analytics-engine-receives-fda-clearance · biofourmis.com / privacy-policy
• Current Health Clinical operations and revenue cycle
  Best Buy Health describes remote patient monitoring with integrated devices, centralized health data, alarms, clinical observations, and bidirectional EHR integrations; Current Health's patient privacy policy describes a remote patient monitoring system, app, dashboard, and related services used to monitor patients outside clinical environments.
  www.bestbuyhealth.com / remote-patient-monitoring · www.bestbuyhealth.com / insights / news · currenthealth.com / patient-privacy-policy · currenthealth.com / privacy-policy
• Huma Cloud Platform Clinical operations and revenue cycle
  Huma describes the Huma Cloud Platform as infrastructure for AI and digital-first health products, including analytics, AI agents, ML tools, regulated applications for patient flow, RPM, clinical dashboards, and a Workspace used to build and operate care workflows, data, and AI.
  www.huma.com · docs.huma.com / workspace · docs.huma.com / workspace / huma-app
• John Snow Labs Healthcare NLP Clinical operations and revenue cycle
  John Snow Labs describes Healthcare NLP as a healthcare-specific NLP and medical language-model stack with thousands of pretrained models for clinical text, biomedical text, de-identification, named entity recognition, assertion, relation extraction, terminology mapping, summarization, and data curation; de-identification materials describe support for free text, tabular data, FHIR, PDFs, DICOM, and other clinical formats, while the privacy policy separately covers website and online-service data.
  www.johnsnowlabs.com / healthcare-nlp · www.johnsnowlabs.com / deidentification · www.johnsnowlabs.com / privacy-policy
• Hippocratic AI Patient access, triage, and agents
  Hippocratic AI presents Polaris-powered healthcare voice agents, says its agents do not diagnose or prescribe, describes more than 1,000 role-specific agents across patient access and clinical operations, lists AI Front Door and Nurse Co-Pilot products, and states that safety testing includes licensed clinicians, output testing, and real-time escalation to human nurses.
  hippocraticai.com · hippocraticai.com / safety · hippocraticai.com / polaris · hippocraticai.com / privacy-policy · hippocraticai.com / universal-health-services-launches-hippocratic-ais-generative-ai-healthcare-agents-to-assist-with-post-discharge-patient-engagement
• Tucuvi Patient access, triage, and agents
  Tucuvi describes LOLA as a clinical voice AI agent for outbound and inbound patient conversations, a dashboard that stratifies patients and alerts clinicians, human-in-the-loop anomaly review, EHR/CRM interoperability through API, FHIR, and connectors, and quality materials that state CE-marked SaMD, ISO 13485, ISO 27001, SOC II, HIPAA, and GDPR claims.
  www.tucuvi.com · www.tucuvi.com / ai-platform · www.tucuvi.com / quality-and-safety · www.tucuvi.com / privacy-policy · www.tucuvi.com / legal
• Infermedica Patient access, triage, and agents
  Infermedica describes symptom checking, triage, intake, and API-based patient navigation; its documentation distinguishes a stateless Engine API from the stateful Platform API and says the Engine API itself is not a standalone medical device.
  infermedica.com / product / symptom-checker · developer.infermedica.com / documentation / overview · developer.infermedica.com / documentation / engine-api
• Ubie Patient access, triage, and agents
  Ubie describes an AI symptom checker that uses a short questionnaire to generate possible causes and says its medical information is based on publications and provider input; its privacy policy lists health-related inputs, symptom history, medication details, and healthcare-visit information as data that may be processed.
  ubiehealth.com · ubiehealth.com / how-ubies-ai-works · ubiehealth.com / clinical-data-sources · ubiehealth.com / privacy-policy
• Hyro Patient access, triage, and agents
  Hyro describes responsible AI agents for patient support, call center automation, scheduling, and smart routing across phone, web, SMS, and mobile channels, with explainability, control, and compliance positioned as deployment pillars.
  www.hyro.ai · www.hyro.ai / healthcare · www.hyro.ai / privacy-policy
• Infinitus Patient access, triage, and agents
  Infinitus describes healthcare AI agents that handle access, affordability, adherence, benefit verification, prior authorization, appeals, provider calls, and patient services, with Studio for guarded agent design, Lens for conversation analysis, and privacy materials covering interactions with AI agents.
  www.infinitus.ai · www.infinitus.ai / product / ai-agents · www.infinitus.ai / safety-first-ai · www.infinitus.ai / privacy
• Artera Harmony Patient access, triage, and agents
  Artera describes Harmony as an all-in-one patient communications platform with workflow automation, vendor/EHR integration, messaging orchestration, AI agents, staff co-pilot capabilities, and patient access workflows; its privacy policy distinguishes general services data from PHI handled in the provider relationship.
  artera.io · artera.io / product · artera.io / patient-communication-software · artera.io / privacy-policy
• Fabric Patient access, triage, and agents
  Fabric describes a hybrid care enablement platform with conversational AI, physician-built clinical logic, digital front door workflows, triage, routing, and virtual care, plus security and compliance materials for healthcare deployments.
  www.fabrichealth.com · www.fabrichealth.com / about · www.fabrichealth.com / security-compliance
• Corti Patient access, triage, and agents
  Corti describes a healthcare AI platform with models, speech-to-text, text generation, coding, an agentic framework, and pre-built agents for clinical and administrative workflows.
  www.corti.ai · www.corti.ai / agentic-framework · www.corti.ai / news / corti-launches-agentic-infrastructure-to-scale-ai-deployment-in-healthcare
• Sully.ai Patient access, triage, and agents
  Sully.ai presents healthcare AI agents for hospitals and says its documentation product converts patient conversations into structured clinical notes, supports EHR integration, medical coding extraction, multilingual workflows, and production API patterns.
  www.sully.ai · docs.sully.ai / documentation / overview
• Memora Health Patient access, triage, and agents
  Memora describes an AI-enabled care platform for personalized text-based journeys, care-team automation, symptom management, check-ins, patient-reported outcomes, education, and escalation support; its privacy policy warns the service is not intended for emergencies.
  www.memorahealth.com / index · www.memorahealth.com / platform · www.memorahealth.com / legal / privacy-policy · www.memorahealth.com / service / cancer-care
• Ada Health Patient access, triage, and agents
  Ada describes enterprise symptom assessment, care navigation, clinical handover, and insights; its help and privacy pages state that Ada is not a substitute for medical advice and that Ada Assess is registered as an EU MDR Class IIa medical device, with jurisdiction-specific limits to verify.
  about.ada.com / enterprise · ada.com / help / what-degree-of-liability-does-ada-accept · about.ada.com / press / 221215-ada-health-receives-eu-mdr-certification · ada.com / privacy-policy
• Mediktor Patient access, triage, and agents
  Mediktor presents an empathy-driven AI healthcare assistant and business platform for insurers, providers, telemedicine, pharma, and public-health workflows, with pages describing AI Medical Agent, clinical validation, security, privacy, and official certifications.
  www.mediktor.com / en-us · site.mediktor.com / ai-medical-agent · www.mediktor.com / en / our-ai-platform · www.mediktor.com / en / security · www.mediktor.com / en / privacy-policy
• Luma Health Navigator Patient access, triage, and agents
  Luma describes Navigator as an AI-powered patient self-service solution and Spark as an operational AI core for patient access and staff workflows; public security and policy materials describe healthcare privacy, security controls, AI data boundaries, and policy documentation that still need customer-contract review.
  www.lumahealth.io / patient-success-platform / ai-navigator · www.lumahealth.io / newsroom / press-releases · www.lumahealth.io / security-and-trust · policy.lumahealth.io / 01-introduction.html · www.lumahealth.io / wp-content / uploads
• Clearstep Smart Care Routing Patient access, triage, and agents
  Clearstep describes Smart Access Suite Virtual Triage as an AI chat and voice symptom-checking and care-navigation workflow built around Schmitt clinical content, configurable routing, EHR/CRM integration options, security controls, and privacy terms.
  www.clearstep.health / virtual-triage · content.clearstep.health / capabilities / ai-chat-triage-care-navigation · content.clearstep.health / capabilities / ai-voice-triage-and-care-navigation · www.clearstep.health / security · www.clearstep.health / privacy
• Canary Speech Patient access, triage, and agents
  Canary Speech describes a vocal biomarker platform for screening mood, cognitive, neurological, and wellness signals from speech; company security materials describe HIPAA-aligned SaaS, de-identified research data handling, encryption, audits, HITRUST e1, ISO 27001, and ISO 42001 posture.
  canaryspeech.com · canaryspeech.com / voice-biomarkers · canaryspeech.com / security-and-compliance · canaryspeech.com / faq · static.v2.canaryspeech.com / _common / PrivacyPolicyENFINAL082422.html
• Ellipsis Health Patient access, triage, and agents
  Ellipsis Health describes voice AI for healthcare and mental-health measurement, including speech-based depression and anxiety screening; company materials emphasize consent, privacy, and limited-purpose use, while peer-reviewed and partner research describe feasibility and real-world depression-detection validation.
  www.ellipsishealth.com · www.ellipsishealth.com / faq · www.ellipsishealth.com / research / how-does-ellipsis-health-keep-sensitive-data-safe-nine-questions-answered · www.ellipsishealth.com / research / breakthrough-study-validates-voice-ai-for-real-world-depression-detection-in-healthcare · pubmed.ncbi.nlm.nih.gov / 35478769
• Syllable Healthcare Agents Patient access, triage, and agents
  Syllable describes a platform for production AI agents, healthcare receptionist examples, voice/SMS/chat/web channels, Epic EHR scheduling and patient-workflow integration, observability, and security controls including healthcare-oriented compliance claims.
  syllable.ai · syllable.ai / integrations / epic-ehr · syllable.ai / agent-channels · docs.syllable.ai · syllable.ai / legal / privacy-policy
• Assort Health Patient access, triage, and agents
  Assort Health describes AI voice agents for healthcare patient access across scheduling, referrals, intake, routing, proactive outreach, care gaps, and payments, with specialty-specific workflows, EHR/PMS integrations, patient journey memory, automated QA, and privacy materials addressing HIPAA-governed patient information.
  www.assorthealth.com · www.assorthealth.com / platform · www.assorthealth.com / activate · www.assorthealth.com / patient-privacy-policy · www.assorthealth.com / privacy
• Anima Health Patient access, triage, and agents
  Anima describes an integrated primary-care platform that combines online consultation, contextual triage questionnaires, appointments, document processing, analytics, messaging, collaboration, AI receptionist, EMIS/SystmOne/GP Connect/PDS integrations, and an Annie scribe product; its security and compliance materials describe NHS supplier status, IM1, DSPT, DCB0129/DCB0160 support, DTAC alignment, Cyber Essentials Plus, UK GDPR, UK AWS hosting, and data-processing details.
  www.animahealth.com · www.animahealth.com / patients · www.animahealth.com / security-compliance · www.animahealth.com / products / scribe · www.animahealth.com / privacy-policy
• Limbic Access Patient access, triage, and agents
  Limbic describes Access as a clinical AI assistant for behavioral-health intake and assessment; NICE HTG756 says Limbic Access is a UKCA Class IIa AI chatbot for NHS Talking Therapies digital-front-door information gathering during evidence generation, while Limbic research and legal pages describe assessment accuracy claims, instructions for use, privacy materials, and a field safety notice page.
  limbic.ai / access · www.nice.org.uk / guidance / htg756 · www.nice.org.uk / guidance / htg756 · limbic.ai / research / improving-clinical-assessments · limbic.ai / care-privacy · limbic.ai / access-instructions-for-use · limbic.ai / uk-field-safety-notice
• Wysa Patient access, triage, and agents
  Wysa describes an AI-powered conversation space, clinically verified tools, human coach and healthcare-professional options, and institutional services; its FDA Breakthrough announcement is limited to a specific CBT tool for adults with chronic musculoskeletal pain and associated depression and anxiety, while privacy and FAQ materials describe AI chatbot data use, safeguards, and limits on diagnosis or medical advice.
  www.wysa.com · blogs.wysa.io / blog / research · www.wysa.com / faq-clinical-program · legal.wysa.io / privacy-policy · legal.wysa.io / assure / privacy-policy
• Woebot Health Patient access, triage, and agents
  Woebot Health describes chat-based AI wellness tools and an AI governance approach with clinical oversight, testing, IRB-reviewed studies, HIPAA-oriented data handling, and limits on crisis intervention; company announcements describe FDA Breakthrough Device Designation and a pivotal trial for the investigational WB001 postpartum-depression digital therapeutic.
  woebothealth.com · woebothealth.com / technology-overview · woebothealth.com / ai-core-principles · woebothealth.com / privacy-webview · woebothealth.com / woebot-health-receives-fda-breakthrough-device-designation · woebothealth.com / woebot-health-enrolls-first-patient-in-pivotal-clinical-trial-of-wb001-for-postpartum-depression
• K Health Patient access, triage, and agents
  K Health describes AI Physician Mode and integrated primary care with top health systems, a symptom checker that uses structured health AI interviews and explicitly says suggested conditions are not a diagnosis, and privacy materials covering OHCA/HIPAA handling plus AI model and service improvement uses.
  khealth.com · khealth.com / symptom-checker · khealth.com / privacy-policy · khealth.com / wp-content / uploads
• MedAware Medication safety and dosing
  MedAware describes an AI-powered medication safety monitoring platform that uses machine learning and outlier detection to identify medication-related risks, support 24/7 monitoring, reduce alert burden, and integrate into existing health data systems or partner environments.
  www.medaware.com · www.medaware.com / technology · www.medaware.com / resources
• DrFirst Clinical-Grade AI Medication safety and dosing
  DrFirst describes clinical-grade AI for medication management that uses natural language processing and machine learning to analyze gaps and inconsistencies in medication records, infer incomplete details when safe, and codify free text into discrete EHR data elements; SmartSig materials describe AI support for medication histories and reconciliation workflows.
  drfirst.com / clinical-grade-ai · drfirst.com / news / press-releases
• DoseMeRx Medication safety and dosing
  DoseMeRx describes itself as a Bayesian dosing platform for clinical practice, using clinically validated pharmacokinetic models, patient characteristics, and drug concentrations to guide dose optimization; product pages also describe HITRUST certification, integrations, and support for multiple therapeutic areas.
  doseme-rx.com · doseme-rx.com / why-dosemerx / product · help.doseme-rx.com / en / articles · dosinginstitute.com / about
• InsightRX Nova Medication safety and dosing
  InsightRX describes Nova as precision dosing clinical decision-support software that personalizes drug dosing with patient data over time, integrates with EHR and surveillance tools, and uses a documented process to verify pharmacokinetic models for dosing accuracy.
  www.insight-rx.com / solutions / providers · blog.insight-rx.com / resources / insightrx-nova-verification-pk-models-precision-dosing · www.insight-rx.com / life-sciences / nova · www.insight-rx.com / privacy-policy
• Arine Medication safety and dosing
  Arine describes an AI-powered medication intelligence platform for health plans and at-risk providers, using clinical, behavioral, social, pharmacy, and medical data to identify medication-related problems and support tailored recommendations, MTM, prescriber outreach, and high-risk patient programs.
  www.arine.io · www.arine.io / our-approach · www.arine.io / resonate · www.arine.io / elevate-mtm · www.arine.io / luminate
• Bluesight Prism Medication safety and dosing
  Bluesight describes Prism as an AI platform for hospital pharmacy and compliance teams; its first product, Prism Assistant, is available in ControlCheck and lets diversion teams query controlled-substance and behavioral insights with natural language.
  bluesight.com / prism · bluesight.com / news / bluesight-launches-prism-an-ai-platform-built-for-health-systems · bluesight.com / about · bluesight.com / privacy-policy
• EveryDose Provider Medication safety and dosing
  EveryDose describes Provider as a standalone or EHR-integrated platform for care teams to monitor adherence, identify medication issues, provide education, capture patient-reported data with conversational AI, and sync medication lists; its security page describes HIPAA, BAA, Azure hosting, encryption, role-based permissions, monitoring, and incident response controls.
  www.everydose.ai · www.everydose.ai / provider · www.everydose.ai / products / medication-safety · www.everydose.ai / company / security
• DreaMed endo.digital Medication safety and dosing
  DreaMed describes endo.digital as a cloud-based SaaS diabetes care pathway with FDA-cleared algorithm intelligence for personalized insulin treatment recommendations; FDA records list K232722 for the endo.digital Platform, and AccessGUDID describes the earlier Advisor Pro workflow as physician-reviewed insulin therapy adjustment recommendations from CGM, SMBG, pump, and meal data.
  dreamed.ai / product · dreamed.ai / about-us · www.accessdata.fda.gov / scripts / cdrh · accessgudid.nlm.nih.gov / devices / 07290017735016
• GenXys TreatGx Medication safety and dosing
  GenXys describes TreatGx as clinical decision support software for precision prescribing that integrates pharmacogenomic data with patient health records and uses evidence-based algorithms, CPIC, PharmGKB, FDA pharmacogenomic markers, drug interaction data, side-effect sorting, and EHR/EMR or pharmacy management system integration.
  www.genxys.com / clinical-decision-support-system · www.genxys.com / genxys-one · www.genxys.com / conditions-and-medications · www.genxys.com / references
• FDB Meducation Medication safety and dosing
  FDB describes Meducation as personalized medication instructions in more than 30 languages for discharge, pharmacy, ambulatory, paperless, and bedside workflows; FDB says AI-powered NLP has supported Meducation since 2018 and that AI outputs are tested and validated with clinical expert oversight.
  www.fdbhealth.com / solutions / meducation-patient-medication-instructions · www.fdbhealth.com / insights / articles · www.fdbhealth.com / about-us / press-releases · www.fdbhealth.com / privacy-notice
• AiCure Medication safety and dosing
  AiCure describes H.Code and Patient Connect as AI-powered adherence and patient-engagement platforms for clinical trials and patient care; company privacy and security materials describe PHI handling, encrypted storage, HIPAA/GDPR/21 CFR Part 11 posture, ISO 27001 and SOC 2 certifications, and facial image and health-data processing that require careful consent and governance review.
  aicure.com · aicure.com / solutions / aicure-platform · aicure.com / solutions / patient-connect · aicure.com / company / data-privacy-security · aicure.com / privacy-policy
• Medisafe Maestro Medication safety and dosing
  Medisafe describes its platform as a pharma patient-engagement engine combining behavioral science, predictive AI, personalized digital experiences, Maestro journey orchestration, JITI machine-learning risk prediction, omnichannel engagement, and privacy terms that cover medication and health information processing.
  medisafe.com · medisafe.com / platform · medisafe.com / privacy-policy
• Synapse Medication Shield Medication safety and dosing
  Synapse Medicine describes Medication Shield as an artificial intelligence solution for pharmacovigilance that uses NLP to code adverse drug event reports with MedDRA terminology and prioritize them by severity; related materials describe ANSM/CRPV collaboration, data-protection posture, Synapse Prescribe AI-driven e-prescribing support, and ONC certification disclosures.
  www.synapse-medicine.com / pharmacovigilance · www.synapse-medicine.com / synapse-prescribe · www.synapse-medicine.com / blog / blogpost · www.synapse-medicine.com / fr / medication-shield-pharmacovigilance
• RxLogix PV Signal Medication safety and dosing
  RxLogix describes PV Signal as an AI-powered pharmacovigilance signal product using AI, NLP, literature mining, global safety databases, and real-world data for signal detection and workflow automation; platform materials describe cloud-native PV lifecycle coverage, GxP/HIPAA/FDA/EMA support, audit tools, integrations, and enterprise pharmacovigilance adoption.
  rxlogix.com / platform · rxlogix.com / platform / pv-signal · rxlogix.com / platform / safety-in-a-box · rxlogix.com / company
• ArisGlobal LifeSphere Safety Medication safety and dosing
  ArisGlobal describes LifeSphere Safety as a unified pharmacovigilance platform using Safety AI and automation powered by LifeSphere NavaX; company materials describe NavaX as a cognitive computing engine with GenAI, LLM, NLP, ML, signal detection, safety-case automation, and regulated life-sciences workflow support.
  www.arisglobal.com / lifesphere / safety · www.arisglobal.com / media / press-release · www.arisglobal.com / media / press-release · www.arisglobal.com / media / press-release
• Oracle Safety One Argus Medication safety and dosing
  Oracle documentation describes Safety One Argus as a next-generation pharmacovigilance platform for end-to-end adverse event case processing from intake to regulatory reporting, using artificial intelligence and machine learning to enhance efficiency, accuracy, and compliance.
  docs.oracle.com / en / industries · docs.oracle.com / en / industries · www.oracle.com / life-sciences / safety
• IQVIA Vigilance Detect Medication safety and dosing
  IQVIA describes Vigilance Detect as a GenAI-powered, AI-driven pharmacovigilance platform for automatically detecting and extracting drug safety events from emails, audio, documents, and chats; IQVIA's broader safety materials describe AI, ML, NLP, connected intelligence, vigilance platform, and pharmacovigilance services.
  www.iqvia.com / library / fact-sheets · www.iqvia.com / solutions / safety-regulatory-compliance · www.iqvia.com / AI
• Veeva Vault Safety AI Medication safety and dosing
  Veeva describes Vault Safety as a global adverse event management and oversight system for clinical and post-marketed products, with built-in gateway connections, reporting rules, dictionary management, Safety Signal, SafetyDocs, Safety Workbench, and Veeva AI for Safety references.
  www.veeva.com / products / vault-safety-ai · www.veeva.com / products / vault-safetydocs · www.veeva.com / wp-content / uploads
• Prenosis Sepsis ImmunoScore Precision medicine and data
  Prenosis describes Sepsis ImmunoScore as an FDA De Novo-authorized AI sepsis diagnostic and predictive tool that combines up to 22 patient parameters, biomarkers, vital signs, demographics, and EHR data; FDA records list DEN230036, and Roche navify materials describe cloud-based algorithm-suite deployment and intended-use boundaries.
  prenosis.com / sepsis-immunoscore · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / reviews · navify.roche.com / us / en-us
• Cytovale IntelliSep Precision medicine and data
  Cytovale describes IntelliSep as an FDA-cleared rapid in vitro diagnostic test for sepsis that uses microfluidics, deformability cytometry, high-throughput image analysis, and machine learning to translate white-blood-cell features into an IntelliSep Index band; FDA K220991 describes the cleared adult ED suspected-infection intended use and states the test should be used with other clinical information and judgment.
  cytovale.com / our-solution / intellisep-sepsis-test · cytovale.com / who-we-help / lab-professionals · www.accessdata.fda.gov / cdrh_docs / reviews · onlinelibrary.wiley.com / doi / full · cytovale.com / learning-hub / evidence · cytovale.com / privacy-statement-us
• Anumana ECG-AI Precision medicine and data
  Anumana describes ECG-AI as a cardiology AI platform that applies FDA-cleared algorithms to standard 12-lead ECGs; FDA records list cleared Anumana ECG-AI algorithms for low ejection fraction and pulmonary hypertension, and Anumana's materials describe health-system workflow integration and U.S. commercial availability for ECG-AI.
  anumana.ai / our-platform · anumana.ai / for-healthcare-providers · anumana.ai / anumana-secures-fda-clearance-for-first-of-its-kind-ecg-ai-algorithm-for-early-detection-of-pulmonary-hypertension · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh · anumana.ai / privacy-policy
• Eko Health SENSORA Precision medicine and data
  Eko describes SENSORA as an FDA-cleared enterprise cardiovascular detection platform that integrates with Eko digital stethoscopes and analyzes heart sounds and ECG to help clinicians identify signs of atrial fibrillation, structural murmur, low ejection fraction, and normal sinus rhythm; Eko regulatory, security, privacy, and FDA-clearance materials describe product clearances, adult-use and physician-review boundaries, encryption, HIPAA handling, and the EFAST algorithm clearance.
  www.ekohealth.com / pages / sensora · www.ekohealth.com / blogs / newsroom · support.ekohealth.com / hc / en-us · support.ekohealth.com / hc / en-us · support.ekohealth.com / hc / en-us · www.accessdata.fda.gov / cdrh_docs / pdf21
• AliveCor Kardia 12L Precision medicine and data
  AliveCor describes Kardia 12L as an FDA-cleared AI-powered handheld 12-lead resting ECG system for healthcare professionals; official product, IFU, privacy, security, and clearance-announcement materials describe KAI 12L determinations, simplified lead placement, KardiaPro data handling, and security certifications to verify before deployment.
  alivecor.com / products / kardia12l · alivecor.com / en / press · alivecor.com / press / press_release · alivecor.com / assets / pdf · alivecor.com / privacy / en · alivecor.com / security
• Philips Cardiologs Holter Precision medicine and data
  Philips describes Cardiologs as medical-grade AI for ECG analysis and says Cardiologs Holter uses deep neural networks and cloud technology for continuous ambulatory ECG review; Philips intended-use materials and FDA records describe qualified-healthcare-professional use, arrhythmia assessment, advisory interpretation, 510(k) status, API or ECG-system interfacing, and non-use in life-supporting or alarm-device monitoring.
  www.usa.philips.com / healthcare / ambulatory-monitoring-and-diagnostics · www.usa.philips.com / healthcare / technology · www.philips.co.uk / healthcare / support · www.accessdata.fda.gov / cdrh_docs / pdf25 · www.accessdata.fda.gov / cdrh_docs / pdf24 · www.philips.com / productsecurity
• Tempus Precision medicine and data
  Tempus describes an AI-enabled precision medicine platform with Tempus One, Hub, Lens, Pixel, Next Pathways, Next Trials, assays, and algorithms; official technology and privacy pages should be checked for product-specific clinical, lab, data, and PHI boundaries.
  www.tempus.com · www.tempus.com / about-us / tempus-tech · www.tempus.com / about-us / tempus-tech · www.tempus.com / privacy-policy · www.tempus.com / tempus-privacy-and-compliance-policies
• Tempus One Precision medicine and data
  Tempus describes Tempus One as a generative AI-enabled assistant for healthcare providers and researchers that can surface patient insights from clinical and molecular data, support EHR workflows, summarize histories and biomarkers, search trials, and process unstructured multimodal data; Tempus announcements also describe EHR integration, guideline access, documentation support, and custom agent-building capabilities.
  www.tempus.com / solutions / one · www.tempus.com / life-sciences / tempus-one · www.tempus.com / news / introducing-tempus-one-in-the-ehr-with-integrated-guidelines · investors.tempus.com / news-releases / news-release-details · www.tempus.com / privacy-policy · www.tempus.com / tempus-privacy-and-compliance-policies
• SOPHiA GENETICS Precision medicine and data
  SOPHiA GENETICS describes SOPHiA DDM as an AI platform for precision medicine spanning genomic, radiomic, and multimodal data, with diagnostic-mode and data-protection distinctions to verify.
  www.sophiagenetics.com / sophia-ddm · www.sophiagenetics.com · www.sophiagenetics.com / downloads
• Guardant InfinityAI Precision medicine and data
  Guardant Health describes InfinityAI as purpose-built AI and machine learning for precision oncology, including multimodal data foundations, self-service cohort exploration, molecular pattern analysis, and real-world clinical-genomic data products.
  guardanthealth.com / products / infinityai · investors.guardanthealth.com / press-releases / press-releases · investors.guardanthealth.com / press-releases / press-releases
• ArteraAI Prostate Precision medicine and data
  Artera describes ArteraAI Prostate as a multimodal AI test using digital pathology images and clinical data to estimate long-term outcomes and therapy benefit; official clinician materials cite NCCN guideline positioning, FDA documentation covers De Novo DEN240068 for ArteraAI Prostate, and partner materials describe a Tempus-integrated mHSPC clinical launch.
  artera.ai / for-clinicians · artera.ai / news / artera-receives-u-s-fda-de-novo-marketing-authorization-for-ai-digital-pathology-software-revolutionizing-prostate-cancer-care · www.accessdata.fda.gov / cdrh_docs / pdf24 · artera.ai / hipaa-notice · www.tempus.com / news / pr
• Avenda Unfold AI Precision medicine and data
  Avenda describes Unfold AI as FDA-cleared AI decision-support software that uses standard-of-care prostate MRI, fusion biopsy, pathology, and PSA data to generate a 3D cancer estimation map; FDA 510(k) K221624 covers Avenda Health AI Prostate Cancer Planning Software, and Avenda materials describe U.S. provider availability plus Category III code and CMS payment milestones.
  avendahealth.com / unfold-ai-based-decision-support · avendahealth.com · avendahealth.com / press / first-ai-powered-precision-oncology-platform-for-prostate-cancer-care-iquesttm-receives-fda-clearance · www.accessdata.fda.gov / cdrh_docs / pdf22 · avendahealth.com / press / cms-establishes-national-payment-for-ai-breakthrough-in-prostate-cancer-diagnosis-unfold-ai · avendahealth.com / privacy-policy
• Unlearn Precision medicine and data
  Unlearn describes digital twins as AI-generated forecasts of individual trial participants' control outcomes using baseline data and historical clinical data; its privacy notice says AI is used to support clinical trial design and analysis rather than automated decisions about website visitors or customers.
  www.unlearn.ai / digital-twins · www.unlearn.ai / privacy · www.unlearn.ai / blog / how-unlearn-builds-trustworthy-ai-from-messy-clinical-data · www.unlearn.ai / blog / our-strategy-for-navigating-the-regulatory-landscape-of-ai-in-drug-development
• Owkin K Pro Precision medicine and data
  Owkin describes K Pro as an AI agent for biology that uses multimodal patient data and specialized AI skills for drug discovery and development tasks such as target prioritization, patient subgroup characterization, biomarker validation, and statistical report generation.
  www.owkin.com / k-os / k-pro · docs.owkin.com / user-guide / getting-started · www.owkin.com / patient-data-network
• Caris Life Sciences Precision medicine and data
  Caris describes itself as a molecular science and AI company focused on precision medicine, and has announced Caris AI Insights signatures used in molecular tumor board reporting.
  www.carislifesciences.com · www.carislifesciences.com / about · investor.carislifesciences.com / news-releases / news-release-details
• Flatiron Assist Precision medicine and data
  Flatiron describes Flatiron Assist as an EHR-integrated oncology clinical decision support platform that surfaces NCCN Guidelines, customizable pathways, biomarkers, clinical-trial opportunities, and reporting at the point of care.
  flatiron.com / oncology / clinical-decision-support · resources.flatiron.com / point-of-care / cms-confirms-flatiron-assist-clinical-guidelines-meet-eom-requirements
• Truveta Precision medicine and data
  Truveta describes a health data, intelligence, and evidence platform with Truveta Studio, Truveta Intelligence, Tru natural-language research assistance, Truveta Language Model data cleaning, provenance, code-set visibility, and a trusted research environment for audit-ready studies.
  www.truveta.com · www.truveta.com / truveta-studio · www.truveta.com / intelligence · www.truveta.com / truveta-data / truveta-language-model · www.truveta.com / privacy-notice · www.truveta.com / blog / announcement
• Deep 6 AI Precision medicine and data
  Deep 6 AI describes a clinical-trial acceleration platform that uses AI and NLP to search clinical data, identify patients matching trial criteria, support feasibility, and connect research sites and sponsors.
  deep6.ai · deep6.ai / how-it-works · deep6.ai / for-healthcare-organizations · deep6.ai / for-sponsors-and-cros
• Dyania Health Synapsis Precision medicine and data
  Dyania Health describes Synapsis as clinical AI for reading patient medical records and supporting tasks such as clinical trial matching, registry abstraction, real-world evidence, and protocol feasibility.
  dyaniahealth.com · dyaniahealth.com / synapsis-ai · dyaniahealth.com / healthcare-systems · dyaniahealth.com / privacy-policy
• TriNetX Precision medicine and data
  TriNetX describes a global real-world data network for trial feasibility, protocol optimization, patient-population matching, site intelligence, and AI-supported clinical research analytics.
  trinetx.com / accelerate-and-optimize-clinical-trials · trinetx.com / data-sets-analytics · trinetx.com / press-releases / trinetx-unveils-conversational-ai-interface-and-enhanced-api-capabilities · trinetx.com / privacy-cookies
• Medidata AI Precision medicine and data
  Medidata says its AI capabilities are embedded in the Medidata platform, use validated clinical trial data, and support protocol feasibility, enrollment, data quality, operational risk, synthetic control arm, and integrated evidence workflows.
  www.medidata.com / en / clinical-trial-products · www.medidata.com / en / clinical-trial-products · www.medidata.com / en / clinical-trial-products · www.medidata.com / en / trust
• ConcertAI Precision medicine and data
  ConcertAI describes integrated oncology real-world data, AI innovation, and clinical expertise across real-world evidence, accelerated clinical trials, commercial solutions, CancerLinQ, and the Precision Suite, including generative AI for RWE analysis and smarter clinical-trial decisions.
  www.concertai.com · www.concertai.com / news / concertai-introduces-predictive-and-generative-ai-solutions-powered-by-multi-modal-real-world-data-key-partnerships-cara-ai-and-more-at-the-2024-asco-annual-meeting · www.businesswire.com / news / home
• Aetion Evidence Platform Precision medicine and data
  Aetion describes the Evidence Platform as a modular, data-agnostic RWD-to-RWE engine with validated analytical methods, data ingestion, no-code workflows, guardrails, audit trails, and applications such as Substantiate and Generate.
  aetion.com / technology / platform · aetion.com / products / substantiate · evidence-hub.aetion.com / real-world-evidence-at-scale-aetion-launches-in-aws-marketplace · aetion.com / services
• nference nSights Precision medicine and data
  nference describes nSights as a suite of multimodal AI applications using longitudinal EHR and real-world data to support clinical research, drug development, diagnostics, RWE generation, and predictive model development.
  nference.com / nsights · nference.com / data-modality · nference.com / publications · nference.com / privacy-policy
• Dandelion Health Precision medicine and data
  Dandelion Health describes a multimodal precision medicine platform with clinical notes, images, waveforms, EHR data, AI-derived labels, a Clinical AI Marketplace, algorithm validation, bias checks, provenance, and regulatory-grade real-world evidence support.
  dandelionhealth.ai · dandelionhealth.ai / platform · dandelionhealth.ai / clinical-ai-marketplace · dandelionhealth.ai / news / clinical-ai-marketplace-launch · dandelionhealth.ai / glp1-real-world-efficacy · dandelionhealth.ai / sdoh-validation-for-health-equity
• KidneyIntelX.dkd Precision medicine and data
  Renalytix and KidneyIntelX materials describe kidneyintelX.dkd as an AI-enabled prognostic blood test for diabetic kidney disease; FDA De Novo DEN200052 lists KidneyIntelX.dkd with a June 29, 2023 decision date, and company security materials describe CLIA laboratory operations and ISO/IEC 27001 certification.
  www.kidneyintelx.com · www.kidneyintelx.com / clinicians-faqs · www.kidneyintelx.com / data-security · www.accessdata.fda.gov / cdrh_docs / reviews · investors.renalytix.com / news-release / medicare-prices-kidneyintelx-dkd-at-950
• Healthy.io Minuteful Kidney Precision medicine and data
  Healthy.io and Minuteful materials describe Minuteful Kidney as a smartphone-powered home urine ACR test that uses colorimetric analysis, computer vision, and AI; public terms and FDA materials describe prescription-use home testing, 510(k) clearance, albumin and creatinine measurement, and clinician review boundaries.
  minuteful.com · healthy.io / services / kidney · blog.healthy.io / company-news / minuteful-kidney-receives-fda-clearance · minuteful.com / us / kidney · www.accessdata.fda.gov / cdrh_docs / pdf22
• Roche Kidney Klinrisk Algorithm Precision medicine and data
  Roche and KlinRisk materials describe Kidney Klinrisk Algorithm as an AI-powered, locked machine-learning in vitro diagnostic device for estimating CKD progression risk over up to five years; Roche says it received CE marking and is delivered through navify Algorithm Suite, while KlinRisk publishes product and validation materials for the CKD progression model.
  navify.roche.com / marketplace / products · navify.roche.com / gb / en-gb · www.roche.com / media / releases · www.klinrisk.com / ckd · www.klinrisk.com / thescience
• Swift Medical Medical imaging and radiology
  Swift Medical describes an AI-powered digital wound care platform with calibrated wound imaging, wound assessments, documentation, analytics, and coordinated care workflows; its privacy materials describe protected health information handling and data security controls.
  swiftmedical.com · swiftmedical.com / about / why-wound-care · swiftmedical.com / privacy-policy
• Net Health Tissue Analytics Medical imaging and radiology
  Net Health describes Tissue Analytics as an AI-powered mobile wound imaging and analytics platform that uses machine learning and computer vision to segment, classify, and measure wounds and integrate with healthcare software systems.
  www.nethealth.com / solutions / wound-care-tissue-analytics · www.nethealth.com / wound-expert-ehr
• eKare inSight Medical imaging and radiology
  eKare describes inSight as an AI-powered wound management platform for 3D wound imaging, digital measurement, documentation, analytics, and telehealth; support materials describe visible wound types and measurement limitations.
  ekare.ai · ekare.ai / advanced-wound-imaging · ekareinchelp.zendesk.com / hc / en-us · ekareinchelp.zendesk.com / hc / en-us
• Healthy.io Minuteful for Wound Medical imaging and radiology
  Healthy.io describes Minuteful for Wound as an FDA-registered smartphone-powered digital wound management service for 3D scans, automatic measurements, tissue distribution, documentation, monitoring, and remote consultations.
  healthy.io / services / wound · healthy.io / eu / services · www.woundsource.com / product / minuteful-wound
• MolecuLight Medical imaging and radiology
  MolecuLight describes its i:X and DX devices as FDA-cleared Class II point-of-care fluorescence wound imaging tools for detecting regions associated with elevated bacterial loads, measuring wounds, and supporting wound management.
  us.moleculight.com · us.moleculight.com / faq · moleculight.com / faq
• Spectral AI DeepView Medical imaging and radiology
  Spectral AI describes DeepView as a predictive AI wound imaging system using multispectral imaging; FDA's De Novo database lists DeepView AI System, DEN250028, with a May 21, 2026 decision date, and Spectral AI announced De Novo clearance for the burn indication on May 26, 2026.
  www.spectral-ai.com · www.globenewswire.com / news-release / 2026 · www.accessdata.fda.gov / scripts / cdrh
• ModelOp Center AI governance and monitoring
  ModelOp describes healthcare, pharmaceutical, and biotech AI governance support for providers, payers, pharmaceutical companies, and biotech firms, with visibility into AI initiatives and risk-based compliance; platform materials describe lifecycle governance, monitoring, controls, and evidence management.
  www.modelop.com / solutions / healthcare-pharmaceuticals-biotech · www.modelop.com / platform
• Credo AI Platform AI governance and monitoring
  Credo AI describes a platform with AI registry, discovery, risk intelligence, compliance and policy workflows, runtime governance, automated evidence generation, and controls aligned to EU AI Act, NIST AI RMF, ISO 42001, and SOC 2; product materials mention differentiated controls for models used in EU healthcare, while legal materials should be reviewed separately for privacy and contracting terms.
  www.credo.ai / product · www.credo.ai / legal · www.gov.uk / ai-assurance-techniques / credo-ai-responsible-ai-governance-platform
• Mendel Redact AI governance and monitoring
  Mendel describes Redact as a de-identification module that combines deep learning, rule-based systems, a medical ontology, and neuro-symbolic methods to mask PHI while preserving clinical text; related Mendel materials describe healthcare-specific OCR through Retina, source-evidence tracing, and clinical reasoning over unstructured records.
  www.mendel.ai / products / redact · www.mendel.ai / products / retina · www.mendel.ai / post / ai-for-healthcare-needs-clinical-reasoning-skills · www.mendel.ai / privacy
• Fiddler AI Observability AI governance and monitoring
  Fiddler describes AI observability and security for production models, LLM applications, and agents; healthcare materials describe monitoring healthcare agents for PHI exposure, biased advice, claim mishandling, clinical accuracy, guardrails, secure deployment, and auditable records.
  www.fiddler.ai / ai-observability · www.fiddler.ai / resources / agentic-observability-healthcare · docs.fiddler.ai / observability / monitoring
• Arize AI Observability AI governance and monitoring
  Arize describes AI observability and evaluation for LLM applications, agents, and machine-learning systems, with materials that reference tracing, monitoring, metrics, evaluations, and a healthcare sign-up path for ML observability.
  arize.com · arize.com / sign-up-healthcare
• Monitaur AI governance and monitoring
  Monitaur describes AI governance software for defining enterprise governance, managing compliance, automating validation, monitoring model performance, applying standardized governance, and producing transparent reporting, with an insurance-focused positioning.
  www.monitaur.ai · www.monitaur.ai / platform
• Saidot AI governance and monitoring
  Saidot describes an EU-native SaaS platform for AI governance with AI inventory, knowledge-graph-driven risks and controls, AI Act expertise, compliance templates, evidence reuse, and integrations with existing governance workflows.
  www.saidot.ai · www.saidot.ai / product
• Chryso.ai AI governance and monitoring
  Chryso.ai describes an AI governance and compliance platform purpose-built for healthcare and regulated industries, with policy management, virtual training, assessments, control evidence, and AI agent monitoring mapped to frameworks such as NIST AI RMF, HIPAA, CMS HEI, ONC HT1, and state AI laws.
  chryso.ai · www.actava.ai
• ALIGNMT AI AI governance and monitoring
  ALIGNMT AI describes an enterprise healthcare AI governance, compliance, and risk-monitoring platform with governance controls, AI assessments, risk mitigation, AI report cards, real-world monitoring, healthcare AI expertise, and services for providers, payers, and health technology companies; its privacy and terms pages describe provider-facing software services and HIPAA-related handling when identifiable patient information is collected on behalf of providers.
  www.alignmt.ai · www.alignmt.ai / platform · www.alignmt.ai / privacy-policy · www.alignmt.ai / terms-of-service
• Risk Meridian AI governance and monitoring
  Risk Meridian describes an AI governance platform for AI system inventory, risk scoring, control auto-creation, disclosure and policy generation, incident logging, executive certification, review scheduling, audit trails, vendor registers, and board-ready reports; its healthcare section says the platform includes fields for clinical AI systems, HIPAA-compatible controls, and hospital board reporting.
  riskmeridian.com · riskmeridian.com / features · riskmeridian.com / solutions / healthcare · riskmeridian.com / pricing · riskmeridian.com / regulations / traiga
• Censinet RiskOps AI Governance AI governance and monitoring
  Censinet describes RiskOps as a healthcare risk-intelligence platform for third-party, enterprise, systemic, and AI governance workflows; public materials describe identifying hidden AI exposure, connecting AI usage to critical healthcare functions, NIST AI RMF-aligned ERM AI support, third-party AI governance assessments, and a Censinet GRC AI roadmap for orchestrating governance, risk, and compliance across healthcare functions.
  www.censinet.com · www.censinet.com / blog / censinet-delivers-new-ai-cyber-governance-risk-and-compliance-products-and-capabilities-at-vive-2025 · censinet.com / blog / censinet-unveils-censinet-grc-ai-tm-vision-and-delivers-major-platform-innovations-for-healthcare-risk-management-at-vive-2026 · www.censinet.com / perspectives / ai-governance-for-ethical-risk-prediction-in-healthcare
• Trase OS AI governance and monitoring
  Trase describes Trase OS as a governed runtime for AI agents in healthcare, government, and regulated enterprise settings, with policy enforcement, immutable audit logs, data-sovereignty controls, healthcare agent bundles, SDK/API access, third-party agent governance, HIPAA compliance claims, and security documentation including SOC 2 Type I attestation and Type II observation status.
  www.trase.ai · www.trase.ai / security-compliance · www.trase.ai / privacy-policy · www.trase.ai / terms-and-conditions
• ShadowIQ for Healthcare AI governance and monitoring
  ShadowIQ describes its healthcare offering as a HIPAA-grade AI governance platform with inline PHI redaction, BAA-aware routing, HITRUST alignment, FDA SaMD controls, policy enforcement, a registry/evidence surface, and cryptographically signed audit trails for healthcare AI decisions; its privacy and DPA pages should be reviewed before sending PHI or regulated evidence through the service.
  shadow-iq.com / solutions / industry · shadow-iq.com / platform · shadow-iq.com / platform / registry · shadow-iq.com / platform / evidence · shadow-iq.com / legal / privacy · shadow-iq.com / legal / dpa
• Harness.health AI governance and monitoring
  Harness.health describes an enterprise platform for health systems to track, monitor, and govern clinical AI tools, with an AI tool registry, risk classification, contract/vendor tracking, quality monitoring, safety events, compliance reports, and EHR integration; its public privacy and terms pages should be reviewed alongside any customer BAA or deployment agreement.
  www.harness.health · www.harness.health / privacy · www.harness.health / terms
• SAIGE AI governance and monitoring
  SAIGE is described as Avanade's Smart AI Governance Engine, built in collaboration with healthcare organizations and AI governance consortiums to register, track, and manage AI inventory, monitor risks, and support vendor collaboration; Avanade and Duke Health materials describe the Duke ABCDS methodology connection, standardized governance workflow, traceability, transparency, and secure collaboration goals.
  saige.cloud · www.avanade.com / en / newsroom · healthaigovernance.duke.edu / abcds-oversight / abcds-oversight-governance-portal
• Grid Health AI governance and monitoring
  Grid Health describes a platform for health systems to centralize AI visibility, monitor performance across vendor tools, EHR-embedded models, and internal systems, detect drift, understand adoption, track ROI, and provide audit trails for compliance teams.
  www.gridhealth.io · www.gridhealth.io / privacy-policy · www.gridhealth.io / terms-of-service
• Asher Informatics AI governance and monitoring
  Asher Informatics describes a purpose-built healthcare AI governance platform with AI Governance Studio, AI Strategy Studio, and AI Monitoring Studio for clinical, operational, and administrative AI, including multimodal oversight, DICOM-native positioning, regulatory tracking, service-line controls, and operational utility modeling.
  www.asherinformatics.com · www.asherinformatics.com / blog
• Cognome ExplainerAI AI governance and monitoring
  Cognome describes a healthcare AI governance and risk-management platform with ExplainerAI for transparency, model performance analytics, bias and drift monitoring, Epic and healthcare-system integration, and AI Sniffer for discovering unsanctioned AI assets across networks and endpoints.
  cognome.com · cognome.com / explainerai-analytics-for-explainable-ai-governance · cognome.com / ai-sniffer · cognome.com / published-results
• Caresyntax Surgery and procedural intelligence
  Caresyntax describes a vendor-neutral surgical intelligence platform with AI-powered software, devices, and clinical services for surgical quality, efficiency, workflow optimization, outcomes, and value-based care support.
  caresyntax.com / us · caresyntax.com · caresyntax.com / privacy-policy
• Theator Surgery and procedural intelligence
  Theator describes a surgical intelligence platform that captures intraoperative video, applies AI analysis, extracts procedure steps and events, and supports structured surgical intelligence including Surgery-to-Text operative reports.
  theator.io · help.theator.io / hc / en-us · theator.io / privacy-policy
• Proximie Surgery and procedural intelligence
  Proximie describes an operating system for intelligent operating rooms that connects OR people, data, devices, and workflows, including real-time collaboration, surgical video, AI-powered insight, computer vision, and orchestration.
  www.proximie.com · www.proximie.com / legal / privacy-policy
• Medtronic Touch Surgery ecosystem Surgery and procedural intelligence
  Medtronic describes the Touch Surgery ecosystem as an AI-powered solution for turning surgical data into insights, with video analysis for postoperative review and performance assessment; its 2022 announcement described Touch Surgery Enterprise as AI-powered surgical video management and analytics for the OR.
  www.medtronic.com / en-us / healthcare-professionals · news.medtronic.com / 2022-03-09-Medtronic-announces-contract-with-Vizient-for-Touch-Surgery-TM-Enterprise · www.medtronic.com / us-en / privacy-statement.html
• Moon Surgical Maestro Surgery and procedural intelligence
  Moon Surgical describes Maestro as a collaborative robotic platform for minimally invasive surgery with live guidance, instrument compatibility, intelligent scope control through ScoPilot, and Maestro Insights for processing intraoperative data.
  www.moonsurgical.com / maestro-system · moonsurgical.com / maestro-insights · www.moonsurgical.com / security · moonsurgical.com / privacy-notice
• Activ Surgical ActivSight Surgery and procedural intelligence
  Activ Surgical describes ActivSight and the ActivEdge platform as intraoperative surgical intelligence using AR, AI, machine learning, and sensing-based technologies to provide visual insights and real-time information to surgeons.
  www.activsurgical.com · www.activsurgical.com / products · www.activsurgical.com / news / activ-surgical-announces-completion-of-first-ai-enabled-case-using-its-activsightintelligent-light
• Apella Surgery and procedural intelligence
  Apella describes a real-time OR intelligence platform that combines computer vision, ambient AI, predictive analytics, and EHR data to auto-detect OR events, share live room status, forecast delays, and analyze operating-room efficiency; company materials also discuss patient privacy blurring and peer-reviewed ambient-AI performance claims.
  apella.io / product · apella.io / use-cases / prevent-delays · apella.io / use-cases / optimize-capacity · apella.io / blog / apellas-ambient-ai-was-independently-peer-reviewed-heres-what-the-research-found
• Surgical Safety Technologies OR Black Box Surgery and procedural intelligence
  Surgical Safety Technologies describes the OR Black Box and Black Box Platform as AI-driven ambient technology for multimodal data capture, de-identified clinical-experience review, and insights into surgical safety, quality, efficiency, and training.
  www.surgicalsafety.com / solutions / or-black-box · www.surgicalsafety.com / platform / black-box-platform · www.surgicalsafety.com / privacy
• Cydar Maps Surgery and procedural intelligence
  Cydar Medical describes Cydar Maps as a cloud-based AI and data-fusion platform for minimally invasive image-guided surgery, including AI-enhanced case planning, vessel measurements, map overlays, auto-registration, real-time surgical guidance, collaboration, and post-operative assessment.
  cydarmedical.com · cydarmedical.com / plan · cydarmedical.com / guide · documentation.cydarmedical.com / Cydar%20EV%20Maps%20-%20Instructions%20for%20Use%20EN.pdf
• Asensus Intelligent Surgical Unit Surgery and procedural intelligence
  Asensus describes the Intelligent Surgical Unit as a real-time augmented-intelligence platform for the Senhance Surgical System, with FDA clearance, CE Mark, PMDA approval, machine-vision-enabled camera control, digital tools, and procedure-data insights for robotic surgery.
  www.asensus.com / isu · www.asensus.com / augmented-intelligence · www.asensus.com / senhance · ir.asensus.com / news-releases / news-release-details
• Proprio Paradigm Surgery and procedural intelligence
  Proprio describes Paradigm as an AI surgical guidance platform for spine surgery that uses multimodal sensors, light-field computer vision, real-time 3D visualization, and structured surgical data; FDA records list Paradigm System 510(k) clearances for stereotaxic spinal instrument guidance, including a 2025 clearance for posterior spine surgery pedicle screw cannulation from thoracic vertebrae to sacrum.
  www.propriovision.com / paradigm · www.propriovision.com / technology · www.propriovision.com / privacy-policy · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf25
• PathKeeper System Surgery and procedural intelligence
  PathKeeper describes the PathKeeper Full Spine Navigation System as an FDA-cleared medical device using AI-driven 3D optical navigation, preoperative CT planning, automated registration, real-time instrument tracking, and radiation-free intraoperative workflow. FDA 510(k) K222355 lists the PathKeeper System as a stereotaxic image-guidance system for posterior approach open spine fusion surgery during pedicle screw placement in the thoraco-lumbo-sacral region when preoperative CT imagery is available.
  www.path-keeper.com · www.path-keeper.com / pktechnology · www.path-keeper.com / privacypolicy · www.accessdata.fda.gov / cdrh_docs / pdf22
• ZEISS Surgery Optimizer Surgery and procedural intelligence
  ZEISS describes Surgery Optimizer as an AI-powered cloud and mobile application for cataract surgical video access, segmentation, KPI review, benchmarking, teaching, and learning; product materials state that the app is a non-medical device and not intended for diagnosis, treatment, or prophylaxis.
  www.zeiss.com / meditec / en · asset-downloads.zeiss.com / catalogs / download · www.zeiss.com / content / dam · apps.apple.com / us / app
• SurgeryView.ai Surgery and procedural intelligence
  SurgeryView.ai describes a secure video-based surgical analytics platform for post-procedure review, with AI PII detection, phase segmentation, analytics tiers, editing, and benchmarking; FAQ and privacy materials state that the platform is not intraoperative guidance and that videos containing patient identifiers should not be uploaded.
  surgeryview.ai · surgeryview.ai / frequently-asked-questions · surgeryview.ai / data-handling-2 · surgeryview.ai / privacy-policy
• Stryker SurgiCount+ with Triton Surgery and procedural intelligence
  Stryker's 2024 launch materials describe SurgiCount+ integrated with Triton technology for sponge management and blood-loss assessment, including AI that differentiates blood from other fluids and EMR-connected workflow support. FDA 510(k) records list SurgiCount+ System software configurations including Triton AI for estimating hemoglobin mass and blood volume on used surgical sponges, SC+ Sponge Counting, Triton QBL, and combined workflows.
  www.stryker.com / us / en · www.stryker.com / us / en · www.accessdata.fda.gov / cdrh_docs / pdf23 · www.stryker.com / gb / en
• Intuitive da Vinci 5 Surgical Insights Surgery and procedural intelligence
  Intuitive describes da Vinci 5 as a robotic surgery platform with enhanced computing, Force Feedback, collaboration, and analytic tools; its 2025 release says Force Gauge, In-Console Video Replay, and Network CCM received FDA 510(k) clearance, while FDA K251213 documents a software modification to enable Force Gauge.
  www.intuitive.com / en-us / products-and-services · investor.intuitivesurgical.com / news-releases / news-release-details · www.intuitive.com / en-us / about-us · www.accessdata.fda.gov / cdrh_docs / pdf25 · www.intuitive.com / en-us / about-us
• TrackiMed Surgery and procedural intelligence
  TrackiMed describes a live OR vision and voice AI platform with ORKing for real-time item recognition and Tracki for structured voice documentation; its public materials say the platform has been validated in live surgeries at Sheba Medical Center, while its privacy policy currently covers website personal data rather than a full hospital deployment data-processing agreement.
  trackimed.com · trackimed.com / privacy-policy
• Radformation AutoContour Medical imaging and radiology
  Radformation describes AutoContour as AI-driven deep-learning contouring software for radiation oncology, with hundreds of CT, MR, and CBCT structure models, DICOM-compatible workflows, Eclipse integration, and guideline-aligned naming; FDA records and Radformation materials should be checked for the exact cleared version and region.
  radformation.com / autocontour · resources.radformation.com / autocontour-white-paper · radformation.com / press / radformation-regulatory-clearances · www.oit.va.gov / services / trm
• MIM Contour ProtegeAI Medical imaging and radiology
  MIM Software announced FDA-cleared Contour ProtegeAI model updates for radiation oncology segmentation, additional structures, molecular radiotherapy enhancements, and flexible workflow implementation; FDA summaries state that automatically generated contours must be reviewed and edited as needed by trained users.
  go.mimsoftware.com / news / mim-software-inc.-announces-fda-clearance-of-contour-protegeai-model-4.0 · go.mimsoftware.com / news / fda-clearance-of-contour-protegeai-plus · www.accessdata.fda.gov / cdrh_docs / pdf22 · go.mimsoftware.com / hubfs / Downloadable%20Content
• Siemens Healthineers DirectORGANS Medical imaging and radiology
  Siemens Healthineers describes DirectORGANS as a deep-learning autocontouring solution embedded in CT simulation, using optimized reconstruction and AI to generate organ-at-risk contours for relevant external-beam radiation therapy sites; Siemens educational materials explain the technical workflow and review need.
  www.siemens-healthineers.com / en-au / radiotherapy · academy.siemens-healthineers.com / en-us / directorgans · academy.siemens-healthineers.com / _ / en-us · builders.intel.com / docs / networkbuilders
• MVision Contour+ Medical imaging and radiology
  MVision describes Contour+ as AI-powered radiotherapy auto-segmentation for organs-at-risk and lymph-node areas, delivered through Workspace+ and GBS workflows; FDA summaries for Contour+ state that CT and MR contours are initial templates that qualified professionals must visualize, review, modify, and approve before clinical use.
  mvision.ai / contour · mvision.ai / guideline-based-segmentation · mvision.ai / gbs-fda-510k-clearance · www.accessdata.fda.gov / cdrh_docs / pdf24
• TheraPanacea Annotate Medical imaging and radiology
  TheraPanacea describes Annotate as an AI-driven ART-Plan contouring solution for whole-body organs-at-risk and lymph nodes, with batch automation, cloud-based workflow, consensus-guideline alignment, and ongoing model evaluation; buyers should verify module-specific FDA or CE status and local deployment terms.
  www.therapanacea.us / annotate · www.therapanacea.us / ai-cancer-treatment-solutions · www.therapanacea.us / copy-of-smartplan · www.therapanacea.eu / our-products / annotate
• Mirada DLCExpert Medical imaging and radiology
  Mirada describes DLCExpert as deep-learning software for CT organ-at-risk autocontouring in radiation oncology, with zero-click workflow support and configurable structure libraries; Mirada materials and NHS AI Award notes emphasize clinical validation and clinician confidence-building for adoption.
  www.mirada-medical.com / radiation-oncology · www.mirada-medical.com / post / mirada-works-with-nhs-on-second-ai-award · www.mirada-medical.com / post / kaposvar-upgrades-to-mirada-zero-click-dlcexpert-ai-autocontouring-solution-consistently-saving-40 · www.astro.org / ASTRO / media
• RayStation Deep Learning Segmentation Medical imaging and radiology
  RaySearch describes machine-learning features in RayStation for automated plan generation and organ segmentation, with deep-learning segmentation models released with RayStation versions and subject to market-specific regulatory clearance; RaySearch's FDA clearance announcement and FDA 510(k) summary for RayStation 8.1 document machine-learning planning and segmentation functionality.
  www.raysearchlabs.com / machine-learning-in-raystation · www.raysearchlabs.com / raystation · www.raysearchlabs.com / media / press-releases · www.accessdata.fda.gov / cdrh_docs / pdf19 · www.raysearchlabs.com / globalassets / digizuite
• GE HealthCare Critical Care Suite Medical imaging and radiology
  GE HealthCare describes Critical Care Suite as on-device X-ray AI for automated measurements, case prioritization, quality control, pneumothorax support, and ET tube positioning; the FDA 510(k) summary for Critical Care Suite states that the pneumothorax function is notification and triage support for adult-size frontal chest X-rays, not a replacement for full patient evaluation or qualified physician image review.
  www.gehealthcare.com / en-us / products · www.accessdata.fda.gov / cdrh_docs / pdf18 · investor.gehealthcare.com / node / 9251
• Imbio Lung Density Analysis Medical imaging and radiology
  Imbio describes Lung Density Analysis Inspiration as automated CT segmentation and quantification of low-attenuation lung areas for emphysema assessment, with FDA 510(k), CE Mark, and Health Canada claims; FDA records list Lung Density Analysis K141069 as an AI-enabled radiology device, and Imbio privacy/terms pages describe privacy, security, international transfer, and uploaded-data responsibility points that need enterprise review.
  www.imbio.com / products / lung-density-analysis-inspiration · www.imbio.com / products / lung-density-analysis-functional · www.accessdata.fda.gov / scripts / cdrh · www.fda.gov / medical-devices / software-medical-device-samd · www.imbio.com / privacy-policy · www.imbio.com / terms-and-conditions
• icometrix icobrain Medical imaging and radiology
  icometrix describes icobrain as validated, FDA-cleared brain MRI AI software for comparing and quantifying neurological scans over time, with disease-specific reports across MS, dementia and Alzheimer's, ARIA, traumatic brain injury, epilepsy, Parkinson's disease, and brain tumors; FDA records list multiple icobrain 510(k) clearances for radiological image-processing software, while icobridge materials describe DICOM pseudonymization, TLS transfer, HIPAA/GDPR handling, and ISO27001 certification.
  www.icometrix.com · www.icometrix.com / evidence · icobridge.icometrix.com / security-and-pseudonymisation · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh
• Behold.ai red dot Medical imaging and radiology
  Behold.ai describes red dot as an AI medical imaging platform for CT and X-ray, including a lung cancer chest X-ray pathway and CT head module; FDA records list Red Dot K191556 as a radiological computer-assisted prioritization device for adult chest X-rays with features suggestive of pneumothorax, and the 510(k) summary says results are for worklist prioritization or triage, not stand-alone clinical decision-making or ruling out pneumothorax.
  www.behold.ai / our-solutions / red-dot-chest-x-ray · www.behold.ai / how-it-works · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf19 · www.behold.ai / case-studies / ai-pneumothorax-triage-in-the-us · www.behold.ai / privacy-policy
• Biobeat Cuffless Blood Pressure Monitoring Clinical operations and revenue cycle
  Biobeat describes cuffless 24-hour blood pressure monitoring with a wireless, non-invasive chest patch and lists multiple FDA 510(k) numbers; FDA records list K241066 for BB-613-BPM and K222010 for Biobeat Platform-2, with Platform-2 intended for healthcare-professional spot-checking and tracking of adult patients in hospitals, clinics, long-term care, and at home, and not intended for critical-care patients.
  www.bio-beat.com · www.bio-beat.com / bpm · www.bio-beat.com / solutions / in-hospital-monitoring · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / pdf22 · www.bio-beat.com / privacy-policy
• Pieces Technologies Clinical operations and revenue cycle
  Pieces describes an EHR-integrated AI platform for clinical summaries, notes, handoffs, discharge planning, and utilization-management workflows; public materials describe SafeRead human-in-the-loop review for AI-generated content, AWS Bedrock-based Sculpted AI, Pieces in Your Pocket for progress-note generation, and privacy terms that should be supplemented by enterprise security and BAA review.
  www.piecestech.com · www.piecestech.com / inpatient-solutions · www.piecestech.com / products / pieces-in-your-pocket · www.piecestech.com / products / pieces-chat · www.piecestech.com / media / pieces-pioneers-sculpted-ai-for-health-systems-using-amazon-bedrock · www.piecestech.com / privacy-policy
• PreciseDx PreciseBreast Digital pathology
  PreciseDx describes PreciseBreast as an AI digital pathology test that uses OncoIntelligence to combine AI-derived grade with clinical factors and generate a recurrence-risk score for early-stage breast cancer; peer-reviewed records describe analytical validation and external validation of the digital prognostic model, while the company privacy policy should be reviewed for data-handling terms before clinical adoption.
  www.precisedx.ai / precisebreast · www.precisedx.ai / publications · pubmed.ncbi.nlm.nih.gov / 38114366 · pmc.ncbi.nlm.nih.gov / articles / PMC12369158 · www.precisedx.ai / privacy-policy
• Lunit SCOPE Digital pathology
  Lunit describes SCOPE as a precision-oncology digital pathology suite for H&E tumor microenvironment analysis, IHC biomarker strategy, genotype prediction, and PD-L1 quantification; its product pages label several SCOPE workflows as research use only and not for diagnostic procedures or decisions, while Lunit's publications and privacy materials provide evidence and data-handling context to verify before clinical or trial adoption.
  www.lunit.io / en / precision-oncology · www.lunit.io / en / precision-oncology · www.lunit.io / en / precision-oncology · www.lunit.io / en / products · www.lunit.io / en / publications · www.lunit.io / en / privacy-policy
• Indica Labs HALO AP and HALO AP Dx Digital pathology
  Indica Labs describes HALO AP as an AI-powered, pathologist-driven digital pathology platform for primary diagnosis, remote working, LIS/LIMS integration, and clinical AI tools; public product materials distinguish HALO AP Dx's FDA-cleared primary-diagnosis scope from HALO AP and several AI modules that are research-use-only in the United States, while FDA K232833 documents HALO AP Dx clearance for a specific whole-slide-image configuration.
  indicalab.com / clinical-products / halo-ap · indicalab.com / clinical-products · www.accessdata.fda.gov / scripts / cdrh · www.hamamatsu.com / us / en · indicalab.com / privacy-policy
• Validic Impact Clinical operations and revenue cycle
  Validic describes Impact as turnkey remote care that lives inside the EHR, writes patient-generated health data to Epic, Cerner or other EHR workflows, supports device logistics and patient onboarding, and adds generative AI summaries for RPM trend review; Validic materials also describe HIPAA, HITRUST, ISO 27001, supported-device breadth, and processor/client data responsibilities that buyers should verify contractually.
  validic.com · validic.com / how-we-help · validic.com / how-we-help / value-based-care · validic.com / news / validic-launches-generative-ai-powered-insights-for-remote-patient-monitoring · validic.com / features / supported-devices · validic.com / privacy-policy · validic.com / data-security-policy
• Awell Clinical operations and revenue cycle
  Awell describes a healthcare workflow-orchestration platform where teams can add vetted AI agents to end-to-end care flows for tasks such as reading faxes, calling patients, summarizing forms, categorizing messages, and surfacing workflow insights; its legal and developer materials describe HIPAA, privacy, security, and BAA considerations that buyers should verify contractually.
  awellhealth.com / platform · awellhealth.com / agents · awellhealth.com / blog / from-rules-to-reasoning-introducing-agentic-care-flows · help.awellhealth.com / en / articles · awellhealth.com / legal / hipaa-at-awell · awellhealth.com / legal / privacy-policy · developers.awellhealth.com / faq
• b.well bailey Patient access, triage, and agents
  b.well describes bailey as a ready-to-deploy white-label health AI assistant built on its Health AI SDK, grounded in longitudinal health records assembled from clinical, claims, pharmacy, and wearable data; public launch, product, privacy, and terms materials emphasize connected health data, FHIR-oriented workflows, security, and consumer-facing assistant limits that buyers should verify for each deployment.
  www.icanbwell.com / ai-health-assistant-bailey · resources.icanbwell.com / bwell-connected-health-unveils-bailey-a-ready-to-deploy-white-label-health-ai-assistant · www.icanbwell.com / artificial-intelligence-solutions · insights.icanbwell.com / hubfs / Web%20Privacy%20Documents%202025 · insights.icanbwell.com / hubfs / Legal
• Welldoc BlueStar Medication safety and dosing
  Welldoc describes its diabetes products as FDA-cleared digital health medical devices for adults with type 1 or type 2 diabetes, with AI-driven coaching, cardiometabolic support, multiple 510(k) clearances, and clinical publications; FDA's AI-enabled device list and Welldoc clearance announcements provide regulatory source trails to verify against the exact product version.
  www.welldoc.com · www.welldoc.com / news / welldoc-11th-510k-clearance-fda-diabetes-platform · www.welldoc.com / news / welldoc-10th-510k-clearance-fda-diabetes-platform · www.welldoc.com / news / fda-clearance-long-acting-insulin-support-bluestar · www.fda.gov / medical-devices / software-medical-device-samd · www.mywelldoc.com / Portal / Guest
• Ailva Clinical evidence and questions
  Ailva describes a free clinical intelligence platform for NPI-verified U.S. healthcare professionals that searches indexed peer-reviewed papers, supports cross-specialty reasoning, verifies citations before delivery, and states that it is not FDA-cleared, not a medical device, and not a substitute for clinician judgment; its privacy policy prohibits PHI entry and describes query retention and self-hosted clinical query processing.
  ailva.ai · ailva.ai / how-it-works · ailva.ai / terms · ailva.ai / privacy
• Eolas Medical Clinical evidence and questions
  Eolas Medical describes a healthcare-specific knowledge platform that indexes local policies, protocols, guidelines, and resources so clinicians can search and receive answers from approved sources; public Ask Eolas materials describe a RAG-based answer engine, while the EULA and privacy materials restrict use to qualified healthcare professionals, prohibit patient-identifiable data, and emphasize independent verification and clinical judgment.
  eolasmedical.com / en-us · www.eolasmedical.com / research-and-case-studies / alpha-release-of-ask-eolas-an-ai-answer-engine-for-clinical-knowledge-retrieval · eolasmedical.com / en-us / legal · www.eolasmedical.com / legal / privacy-policy-v1-3 · trust.eolasmedical.com
• Aiberry Patient access, triage, and agents
  Aiberry describes an AI-powered mental health assessment platform using Botberry-administered conversations and text, audio, and video inputs to generate real-time scores, symptom insights, transcripts, and monitoring; its research pages describe a clinical validation study with UT Austin, Georgetown University, and the University of Arizona and report validation across ages 18 to 74 plus bias analyses by gender, age, ethnicity, and severity.
  www.aiberry.com / solution · www.aiberry.com / research · www.aiberry.com / news / landmark-study-demonstrates-clinical-validation-of-aiberry-ai-powered-mental-health-assessments · app.aiberry.io / privacy-policy · app.aiberry.io / terms-of-use
• Twill Mental Health Sequence Patient access, triage, and agents
  Twill describes its Mental Health Sequence as a configurable digital-first mental health support system built on the Intelligent Healing Platform, combining digital therapeutics or well-being tools, community, coaching, telebehavioral health, integration with existing benefits, and clinician-trained AI such as Taylor; its privacy policy describes PHI, sponsor eligibility data, Taylor chatbot interactions, HIPAA handling where applicable, and business-associate processing when covered by a customer agreement.
  www.twill.health / mental-health · www.twill.health / how-we-do-it · www.twill.health / sequences · www.twill.health / twill-therapeutics · www.twill.health / privacy-policy
• Cognoa Canvas Dx Patient access, triage, and agents
  Cognoa describes Canvas Dx as an FDA-authorized AI and machine-learning diagnostic system for diagnosing or ruling out autism in children ages 1.5 to 6 years; FDA's De Novo record for DEN200069 classifies the Cognoa ASD Diagnosis Aid as a pediatric autism spectrum disorder diagnosis aid, and Cognoa's indications state it is prescription-only, adjunctive, and intended for trained healthcare professionals using patient history, clinical observations, and other evidence.
  cognoa.com · cognoa.com / for-providers · cognoa.com / clinical-research · cognoa.com / ifu · www.accessdata.fda.gov / scripts / cdrh · www.accessdata.fda.gov / cdrh_docs / reviews · app.cognoa.com / link / privacy-policy · cognoa.com / terms-conditions
• Sohar Health Clinical operations and revenue cycle
  Sohar Health describes Verification as a semantic layer on top of payer data for real-time eligibility and benefits checks, with product pages reporting recent median latency and benefit-accuracy metrics; developer docs show verification API responses and statuses, while privacy and security materials describe PHI/PII handling, subprocessors, and compliance posture.
  www.soharhealth.com / products / verification · www.soharhealth.com / products / discovery · docs.soharhealth.com / documentation / getting-started · docs.soharhealth.com / api-reference / verifications · www.soharhealth.com / articles / security-privacy-compliance · www.soharhealth.com / legal / privacy
• Adonis Intelligence Clinical operations and revenue cycle
  Adonis describes Intelligence as an RCM-focused platform combining AI technology and revenue-cycle expertise to surface denial, collection, AR, productivity, underpayment, and overpayment opportunities; launch materials describe predictive analytics, actionable alerting, dashboards, and integrations, while privacy and security pages discuss encryption, access controls, HIPAA training, and personal-information handling.
  www.adonis.io / platform / intelligence · adonis.io / resources / introducing-adonis-intelligence · www.adonis.io / why-adonis · www.adonis.io / privacy-and-security · www.adonis.io / privacy-policy
• SmarterNotes Clinical documentation and scribes
  SmarterDx describes SmarterNotes as a note-generation workflow that uses patient history, labs, medications, vitals, flowsheets, clinical AI, and documentation nudges; Smarter Technologies states that SmarterNotes combines SmarterDx clinical AI with Pieces documentation workflows after acquiring Pieces Technologies, while the Texas Attorney General settlement over Pieces-era healthcare genAI accuracy claims makes accuracy disclosure, human reliance limits, and hallucination monitoring essential diligence items.
  www.smarterdx.com / smarternotes · www.smartertech.com / solutions / smarternotes · www.smarterdx.com / legal / privacy · www.texasattorneygeneral.gov / news / releases · www.aha.org / system / files