Bayesian Health, Inc. - FDA 510(k) Cleared Devices

Bayesian Health, Inc. develops real-time clinical intelligence platforms for proactive patient care. The company partners with leading health systems to deliver continuous patient monitoring and early warning capabilities. With a registered facility in New York, Bayesian focuses on surfacing actionable clinical insights to clinicians at scale.

The company has received 1 FDA 510(k) clearance from 1 total submission. Bayesian's cleared device falls within the Gastroenterology & Urology category. The company achieved its first and latest clearance in 2026, demonstrating active regulatory engagement and current market presence.

Bayesian's platform targets high-impact clinical conditions including sepsis, readmissions, patient deterioration, and palliative care transitions. Real-world data from customer implementations show significant improvements in mortality reduction and length of stay. The company's approach emphasizes clinician trust through reduced false alarm rates and earlier detection windows compared to standard EHR-based algorithms.

Explore the company's cleared device names, product codes, and detailed clearance dates in the database.