Birth Model vs Zio

Zio is a service. A patch records the ECG, a deep neural network flags arrhythmias, cardiac technicians validate the findings and a physician report follows, and the vendor cites 99% physician agreement on end-of-wear reports. iRhythm bills payers through Medicare-enrolled IDTFs and its site lists no price. Cardiology practices and hospitals order it for ambulatory monitoring. FDA sent iRhythm a warning letter on May 25, 2023 over a Zio AT change, and the FY2025 10-K says FDA issues remain open and a further warning letter, consent decree or recall is possible.

Birth Model alerts labor and delivery units to postpartum hemorrhage, preeclampsia and shoulder dystocia, and the vendor says it is built on 150,000 or more patient charts. A cardiology practice ordering ambulatory ECG and an obstetric service buying delivery alerts are separate purchases, since Zio reads ECG for arrhythmia. openFDA lists no clearance for Birth Model, and its homepage and company page make no FDA or non-device statement.