AI devices with FDA product code MWI — Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

Product code MWI (“Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)” in openFDA) covers 5 devices on the FDA AI-enabled list, from 4 companies. Most are reviewed by the Cardiovascular panel (5). The most recent decision was Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal on June 6, 2025.