Regulatory Affairs & FDA
1,451 FDA-Authorized AI/ML Devices — What the Tracker Shows
The FDA has authorized over 1,400 AI/ML-enabled medical devices, with 76% focused on radiology and imaging.
April 22, 2026
Tag
regulatory
Regulatory Affairs & FDA
The EU AI Act and Healthcare: What Clinicians Need to Know
The EU AI Act entered into force in August 2024. Medical AI is classified as high-risk under Annex…
April 8, 2026
AI Diagnostics & Imaging
FDA Has Now Authorized Over 1,451 AI-Enabled Medical Devices
The FDA's AI/ML device tracker has crossed 1,451 authorizations. Here's what the data reveals about where AI in…
March 15, 2026