FDA Clears AI Sepsis Predictor: The De Novo Pathway Just Got a Template
Cognify Health's SepsisAlert 2.0 receives 510(k) clearance after 14-month review — the fastest AI-device approval since the 2023 predicate expansion.
The clearance, announced Tuesday at 6:14 AM ET, applies to adult ICU patients in health systems running Epic or Oracle Health EHRs. The algorithm flags deterioration risk 6 hours before clinical presentation with 84% sensitivity and a false-positive rate that regulators deemed "operationally acceptable" for a decision-support — not decision-making — classification.
For health system CTOs, the operative word is integration. The FDA's special controls memo explicitly requires that SepsisAlert surface alerts within the clinician's existing workflow rather than a standalone interface. That's a procurement signal: any competing vendor without native EHR hooks will face the same regulatory friction.
"The 6-hour prediction window is the clinical threshold that makes this actionable — not just informative."
Dr. Marcus Webb, Contributing Editor
Source: FDA 510(k) Database K253847 · ClinicalTrials.gov NCT05891234
