Regulatory Affairs & FDA
FDA & Peer-Reviewed Sources — How We Verify Every Claim
Every claim on AIHealthTech.io is backed by regulatory data, PubMed citations, and verifiable research. Here is our sourcing…
April 22, 2026
Category
Regulatory Affairs & FDA
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
Regulatory Affairs & FDA
295 New AI Devices Authorized in 2025
The FDA authorized 295 new AI/ML-enabled medical devices in 2025 — a record year.
April 22, 2026
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