Overview
- Bayesian Health’s sepsis flagging device, which won FDA 510(k) clearance Tuesday, is the first cleared system to continuously monitor patients and flag likely sepsis before clinicians suspect it.
- Unlike tests that start after a doctor orders labs, the software scans electronic health records nonstop inside the workflow to spot early changes and prompt next steps.
- A 2022 Nature Medicine study across 764,707 encounters found the tool detected sepsis about 5.7 hours earlier at 82% sensitivity, and when clinicians acted on alerts, in-hospital deaths fell by roughly 18%.
- The technology, developed at Johns Hopkins and previously designated a Breakthrough Device in 2023, has been used at Cleveland Clinic, MemorialCare, and University of Rochester with reported bedside adoption.
- FDA clearance positions the tool for a Medicare New Technology Add-on Payment decision expected in early August, with possible add-on payments starting October 2026, in a condition that costs U.S. hospitals about $50 billion each year.