Medical imaging and radiology
Us2.ai
FDA-cleared AI echocardiography platform that automates measurements, disease-detection support, and structured reporting from DICOM echo studies.
Last updated: June 14, 2026
Back to directoryUltromics EchoGo medical AI product profile
FDA-cleared echocardiography AI that analyzes apical four-chamber clips to support detection of heart failure with preserved ejection fraction.
Medical imaging and radiology
Best fit
Heart-failure and echo programs evaluating structured AI support for HFpEF workups in clinician-reviewed workflows.
- Primary use case
- AI-assisted echocardiography analysis for HFpEF detection support and cardiac workflow reporting
- Audience
- Cardiology, echocardiography labs, heart-failure programs, and hospital outpatient imaging teams
- Risk level
- High
- Pricing signal
- Enterprise and provider pricing; verify current product version, reimbursement code use, and deployment terms.
- Official sources
- 4 official sources
Compare within workflow: Medical imaging and radiology · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared EchoGo Heart Failure 2.0 adjunctive heart-failure status indicator software. |
|---|---|
| Review route | 510(k) K240013. |
| Intended use | Analyzes non-contrast echocardiograms with at least one full cardiac cycle and is used by an interpreting clinician as an aid to HFpEF diagnosis; the final diagnosis remains the clinician's responsibility. |
| Verification note | Confirm the deployed EchoGo version, input echo requirements, image-quality handling, eligible clinical workflow, reimbursement use, report integration, and clinician review policy. |
| Source | www.accessdata.fda.gov / cdrh_docs / pdf24 |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Ultromics EchoGo as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Match the EchoGo Heart Failure version, 510(k) record, indication, product code, geography, and reimbursement workflow before using output in a heart-failure pathway. |
|---|---|
| Privacy | Review echocardiography upload flow, cloud or integration partner processing, customer-controller obligations, retention, deletion, access controls, DPO contact path, and support-data handling. |
| Evidence | Evaluate HFpEF detection evidence, eligible echo views, image-quality failures, false-positive and false-negative burden, patient population fit, and downstream testing or referral impact. |
| Workflow | Best governed as cardiologist-reviewed echo decision support that feeds HFpEF diagnostic workups, structured reporting, and follow-up planning rather than autonomous diagnosis. |
Where Ultromics EchoGo fits
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.
Not for: Standalone heart-failure diagnosis, unsupported echo views, or use outside the cleared indication, product version, and physician-review workflow.
What to verify before using Ultromics EchoGo
- Whether the selected EchoGo Heart Failure version and 510(k) clearance match the intended echocardiography workflow.
- Required echo clip, image quality, integration path, reporting turnaround, and clinician review requirements.
- How patient echocardiography data is transferred, retained, destroyed, and controlled under customer agreements.
- Local performance for HFpEF workups, false positives, false negatives, referral patterns, and reimbursement documentation.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- 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
Related medical AI products
Medical imaging and radiology
Gleamer BoneView
Radiology AI product for detecting and highlighting fractures on trauma X-rays inside clinician-reviewed reading workflows.
Medical imaging and radiology
iCAD ProFound AI
Breast health AI suite for mammography detection, scoring, density assessment, and risk-related workflows.
Medical imaging and radiology
GI Genius
Medtronic endoscopy AI module that overlays real-time markers to help endoscopists detect colonic mucosal lesions during colonoscopy.