FDA Updates List of Artificial Intelligence-Enabled Medical Devices as Regulatory Focus Intensifies

The U.S. Food and Drug Administration has refreshed its public list of cleared and approved artificial intelligence-enabled medical devices, underscoring how clinical AI tools are being evaluated under existing medical device pathways. The update, last revised on August 20, 2026, highlights the growing volume of AI-based software as a medical device and signals continued oversight of safety and effectiveness in clinical settings.