Precision medicine and data
Anumana ECG-AI
Cardiovascular AI platform using standard 12-lead ECGs to surface signals such as low ejection fraction, pulmonary hypertension, and cardiac amyloidosis for clinician follow-up.
Last updated: June 7, 2026
Back to directoryCytovale IntelliSep medical AI product profile
FDA 510(k)-cleared sepsis test that runs on the Cytovale System and returns an IntelliSep Index band for adult ED patients with signs or suspicion of infection.
Precision medicine and data
Best fit
Hospitals that want a rapid, lab-run host-response signal to support supervised ED sepsis triage, protocol decisions, and stewardship review.
- Primary use case
- FDA-cleared host-response in vitro diagnostic test that uses image analysis and machine learning on white-blood-cell biophysical features to aid early sepsis detection and risk stratification in adult ED patients
- Audience
- Emergency departments, clinical laboratories, sepsis committees, nursing triage teams, infectious disease, quality, and hospital operations leaders
- Risk level
- High
- Pricing signal
- Hospital laboratory, Cytovale System, cartridge, service, implementation, and protocol pricing is not public; request current contract, volume, support, and reimbursement terms.
- Official sources
- 6 official sources
Compare within workflow: Precision medicine and data · comparison shortlist · source index
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Cytovale IntelliSep as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as a regulated in vitro diagnostic tied to the Cytovale System, labeled specimen handling, adult ED suspected-infection population, and FDA 510(k) intended use; do not generalize clearance to autonomous diagnosis, organism identification, pediatric triage, or unsupported care settings. |
|---|---|
| Privacy | Review lab-result, instrument, LIS, EHR, support, service, and analytics data flows, plus Cytovale privacy, security, customer-contract, retention, access-control, and covered-entity obligations before implementation. |
| Evidence | Compare FDA decision materials, pooled analysis results, local sepsis prevalence, ED triage criteria, Band 1 false-reassurance risk, Band 3 escalation burden, antibiotic stewardship goals, and post-launch outcome monitoring before scaling. |
| Workflow | Best governed through a joint ED, lab, nursing, infectious disease, pharmacy, quality, and informatics protocol with clear ordering criteria, result interpretation, escalation paths, override documentation, and routine safety review. |
Where Cytovale IntelliSep fits
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.
Not for: Standalone sepsis diagnosis, identifying the infectious organism, pediatric use, use outside ED adult suspected-infection labeling, or replacing clinical assessment, cultures, lactate, imaging, and clinician judgment.
What to verify before using Cytovale IntelliSep
- FDA 510(k) K220991 intended use, any subsequent IntelliSep clearances, adult ED suspected-infection population, prescription-use status, sample requirements, and three-day sepsis-with-organ-dysfunction window.
- How the Cytovale System, K2 EDTA specimen collection, cartridge handling, LIS/EHR interfaces, quality controls, service schedule, and downtime workflow fit the clinical lab and ED triage process.
- How patient identifiers, lab results, instrument data, support access, analytics, retention, security controls, and any customer data-processing or BAA terms are handled.
- Local impact on sepsis bundle timing, antibiotic starts, blood-culture use, false reassurance in low bands, escalation for high bands, clinician acceptance, and post-deployment quality monitoring.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- 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
Related medical AI products
Precision medicine and data
Eko Health SENSORA
FDA-cleared cardiovascular detection platform that pairs Eko digital stethoscopes with AI-supported ECG and heart-sound analysis for supervised point-of-care screening.
Precision medicine and data
AliveCor Kardia 12L
Portable AI-powered 12-lead ECG system that uses a reduced leadset and KAI 12L algorithms to support clinician-reviewed cardiac determinations.
Precision medicine and data
Philips Cardiologs Holter
Cloud-based Philips Cardiologs platform that uses deep-learning ECG analysis to support qualified clinicians reviewing Holter and ambulatory ECG recordings.