AI devices with FDA product code SFR — Hypertension Machine Learning-Based Notification Software

Product code SFR (“Hypertension Machine Learning-Based Notification Software” 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 Hypertension Notification Feature (HTNF) on September 11, 2025.