AI devices with FDA product code MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

Product code MHX (“Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)” in openFDA) covers 3 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Cardiovascular panel (3). The most recent decision was Corvair Monza on January 9, 2026.