Emergency_medicine
Bayesian Health Sepsis Flagging Device
Bayesian Health, Inc.
Continuously monitoring machine-learning software that analyses electronic health record data (patient information, comorbidities, the emergency department chief complaint, laboratory measurements, vital signs, procedures, medications and consult orders) and shows a "Sepsis Risk High" flag in the EHR. It aids healthcare providers, alongside clinical assessment and other laboratory data, in the early detection or risk prediction of sepsis developing within 24 hours. It is for adults from emergency department presentation or hospital admission through the acute care stay, and the flag is not to be used as the sole basis for a sepsis decision.
FDA Submission Metadata
- Submission number
- K250680
- Decision date
- April 2026
- FDA panel
- General Hospital
- Product code
- SAK
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals