Clinical operations and revenue cycle
CLEW ICU
FDA-cleared clinical surveillance platform that uses machine-learning models to surface adult ICU deterioration risk and workflow notifications.
Last updated: June 14, 2026
Back to directoryBayesian Health medical AI product profile
Real-time clinical intelligence platform with an FDA-cleared continuous sepsis flagging device and broader inpatient risk workflow modules.
Clinical operations and revenue cycle
Best fit
Hospitals evaluating governed clinical AI for sepsis, deterioration, or other inpatient risk workflows where alerts need context, clinician trust, and performance monitoring.
- Primary use case
- Real-time EHR-based clinical intelligence, continuous sepsis flagging, patient risk monitoring, care-pathway activation, and performance reporting
- Audience
- Health systems, clinical operations leaders, CMIOs, quality teams, inpatient service lines, and clinical AI governance committees
- Risk level
- High
- Pricing signal
- Enterprise health-system pricing; request current module, integration, and service-line terms.
- Official sources
- 7 official sources
Compare within workflow: Clinical operations and revenue cycle · comparison shortlist · source index
Regulatory snapshot
| Status | FDA-cleared Class II software device for sepsis early detection and/or 24-hour risk prediction in adult acute-care settings. |
|---|---|
| Review route | Traditional 510(k) K250680, substantially equivalent decision on April 30, 2026; product code SAK under 21 CFR 880.6316. |
| Intended use | Continuously monitors EHR data for adult patients on ED presentation or hospital admission, outputs a "Sepsis Risk High" flag in the EHR, and must be used with clinical assessments and laboratory data rather than as the sole basis for sepsis determination. |
| Verification note | Confirm the deployed Bayesian module, acute-care population, EHR inputs, alert display, clinician-response pathway, labeling, model-change controls, local validation, and whether any non-sepsis workflows are separately authorized. |
| Source | www.accessdata.fda.gov / scripts / cdrh |
Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating Bayesian Health as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat the sepsis flagging workflow as high-risk medical-device software and match use to FDA 510(k) K250680; verify intended use, local policy, CDS review, and regulatory posture for any other Bayesian module. |
|---|---|
| Privacy | Do not rely on marketing-site privacy alone; require customer security documentation, BAA terms, EHR integration details, PHI retention, audit logs, access controls, and analytics-data boundaries. |
| Evidence | Review the FDA summary, peer-reviewed evidence, local validation, calibration, alert precision, sensitivity, adoption, equity monitoring, and whether outcome claims reproduce in comparable units. |
| Workflow | Best deployed with pathway owners, clinician education, response protocols, alert escalation rules, override tracking, and ongoing governance review. |
Where Bayesian Health fits
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.
Not for: Unsupervised diagnosis, treatment automation, or alert deployment without clinical pathway ownership and local validation.
What to verify before using Bayesian Health
- Whether the deployment uses the FDA-cleared Bayesian Health Sepsis Flagging Device K250680, another Bayesian module, or a broader clinical pathway workflow.
- Local validation for your EHR data, patient mix, baseline risk, service lines, alert thresholds, and clinical-response workflow.
- How patient data, EHR context, model inputs, alert explanations, logs, and analytics are handled under customer privacy and security terms.
- How adoption, false alerts, missed cases, health-equity impact, mortality or length-of-stay claims, and pathway completion are measured after go-live.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- 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
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