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

Product code SAT (“Pulmonary Hypertension Machine Learning-Based Notification Software” in openFDA) covers 2 devices on the FDA AI-enabled list, from 2 companies. Most are reviewed by the Cardiovascular panel (2). The most recent decision was ECG-AI Pulmonary Hypertension (PH) 12-Lead algorithm (1020) on March 28, 2026.