AI devices with FDA product code QME — Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate

Product code QME (“Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate” in openFDA) covers 7 devices on the FDA AI-enabled list, from 3 companies. Most are reviewed by the Cardiovascular panel (7). The most recent decision was Vital Signs on February 2, 2026.