AI devices with FDA product code HGM — System, Monitoring, Perinatal

Product code HGM (“System, Monitoring, Perinatal” in openFDA) covers 1 device on the FDA AI-enabled list, from 1 company. Most are reviewed by the Obstetrics and Gynecology panel (1). The most recent decision was PeriCALM Patterns 3.0 on January 10, 2025.