AI devices with FDA product code MWJ — Electrocardiograph, Ambulatory (Without Analysis)

Product code MWJ (“Electrocardiograph, Ambulatory (Without Analysis)” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Cardiovascular panel (1). The most recent decision was ASSURE Wearable ECG on May 7, 2024.