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Last updated: June 5, 2026
Back to directoryPrenosis Sepsis ImmunoScore medical AI product profile
FDA De Novo-authorized AI/ML software that assigns adult emergency department or hospital patients to sepsis risk categories within a clinician-reviewed workflow.
Precision medicine and data
Best fit
Hospitals evaluating transparent sepsis risk stratification that combines clinical data and biomarkers with EMR-integrated review for suspected sepsis workflows.
- Primary use case
- FDA-authorized AI diagnostic and predictive sepsis risk assessment using EHR, vital-sign, demographic, laboratory, and biomarker inputs
- Audience
- Emergency departments, inpatient teams, sepsis committees, clinical informatics, quality leaders, and acute-care precision medicine programs
- Risk level
- High
- Pricing signal
- Hospital, algorithm-suite, and enterprise pricing; request current deployment, integration, and reimbursement terms.
- Official sources
- 4 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 Prenosis Sepsis ImmunoScore as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as prescription AI/ML-based medical-device software and match use to FDA De Novo DEN230036, including suspected sepsis context, adult ED or hospital patients, blood-culture workflow, and clinician-review requirements. |
|---|---|
| Privacy | Review EHR, lab, biomarker, and cloud algorithm-suite data flows; PHI transfer; retention; access controls; security certifications; audit logs; and BAA or data-processing terms before production use. |
| Evidence | Validate local performance against sepsis prevalence, laboratory workflows, demographics, comorbidities, SEP-1 objectives, false-positive burden, and missed-sepsis risk rather than relying on authorization alone. |
| Workflow | Best governed through emergency medicine, hospital medicine, infectious disease, nursing, lab, quality, and informatics teams with clear escalation, override, monitoring, and downtime procedures. |
Where Prenosis Sepsis ImmunoScore fits
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.
Not for: Standalone sepsis diagnosis, use outside the FDA-authorized intended population, or replacing laboratory findings, clinical assessment, sepsis protocols, and clinician judgment.
What to verify before using Prenosis Sepsis ImmunoScore
- FDA De Novo DEN230036 intended use, patient eligibility, blood-culture-order requirement, 24-hour risk window, and prescription-use limits.
- Which deployment path is used, including EHR integration, navify Algorithm Suite availability, biomarker inputs, lab interfaces, and downtime procedures.
- How PHI, laboratory data, demographics, vital signs, model parameters, audit logs, and support access are protected under customer and platform agreements.
- Local impact on sepsis bundle compliance, time to treatment, false positives, false negatives, ICU escalation, alert burden, and clinician acceptance.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- prenosis.com / sepsis-immunoscore
- www.accessdata.fda.gov / scripts / cdrh
- www.accessdata.fda.gov / cdrh_docs / reviews
- navify.roche.com / us / en-us
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