Clinical operations and revenue cycle
Regard
AI clinical insights platform that surfaces patient history context and documentation before physician review.
Last updated: June 5, 2026
Back to directoryCLEW ICU medical AI product profile
FDA-cleared clinical surveillance platform that uses machine-learning models to surface adult ICU deterioration risk and workflow notifications.
Clinical operations and revenue cycle
Best fit
Hospitals evaluating predictive surveillance for high-acuity units where ICU teams can govern alert routing, escalation, and local performance monitoring.
- Primary use case
- AI-driven clinical surveillance and predictive alerts for adult ICU patient deterioration and hemodynamic instability
- Audience
- ICU, tele-ICU, rapid response, clinical operations, virtual nursing, and hospital patient-safety teams
- Risk level
- High
- Pricing signal
- Enterprise hospital and partner pricing; request current module, integration, support, and regulatory documentation.
- Official sources
- 6 official sources
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Regulatory, privacy, evidence, and workflow lens
Product-specific review. These product-specific signals summarize what the cited sources imply before treating CLEW ICU as safe for a local clinical, operational, or research workflow.
| Regulatory / FDA | Treat as high-risk medical-device software and match deployment to the FDA-cleared indication, adult critical-care setting, prediction outputs, labeling, and change-control boundaries for K233216. |
|---|---|
| Privacy | Review EHR, bedside-device, tele-ICU, and cloud data flows; BAA terms; PHI retention; access controls; audit logs; security posture; support access; and whether privacy materials are website-only or customer-contract specific. |
| Evidence | Do not rely on clearance alone; validate local performance, alert thresholds, sensitivity, PPV, low-risk labeling, false negatives, false positives, workflow response, and subgroup performance. |
| Workflow | Best governed by ICU, tele-ICU, rapid-response, biomedical, informatics, and patient-safety owners with defined escalation rules, override review, downtime plans, and post-deployment monitoring. |
Where CLEW ICU fits
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.
Not for: Standalone diagnosis, autonomous treatment decisions, non-ICU populations outside the cleared intended use, or deployment without local validation and clinician response protocols.
What to verify before using CLEW ICU
- FDA 510(k) K233216 intended use, adult critical-care setting, product code, decision date, and any predetermined change-control plan boundaries.
- Which prediction models are enabled, how EHR and device data are ingested, and whether alerts route through EMR, tele-ICU, command center, or third-party workflow systems.
- Security documentation, BAA terms, PHI retention, cloud controls, access logs, support access, and how customer data is used for implementation or model monitoring.
- Local sensitivity, positive predictive value, low-risk classification, alert burden, missed deterioration, response time, equity impact, and clinician adoption after go-live.
Source links
Use these links to confirm current claims, terms, regulatory status, pricing, and deployment requirements.
- 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
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