Bayesian Health vs Zio

Bayesian Health's sepsis flag was cleared as K250680 on April 30, 2026. The 2022 Nature Medicine study the vendor cites covers TREWS, the Johns Hopkins system the flag descends from, with 764,707 encounters at five hospitals. The vendor's release summarizes it as 18% lower in-hospital mortality when alerts were acted on and 82% sensitivity. The design was observational, and whether the cleared flag matches the TREWS version is open. Inpatient alerts and outpatient monitoring sit in different clinical workflows. iRhythm, a public company with about 2,400 employees, sells Zio as a patch-based arrhythmia monitoring service. The FDA's warning letter of May 25, 2023 said iRhythm changed Zio AT without clearance and marketed it to a new high-risk population, and the FY2025 10-K says FDA issues remain open and a further warning letter, consent decree or recall is possible. A hospital sepsis program looks at Bayesian. A clinic ordering patches for outpatients with suspected arrhythmias looks at Zio.