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
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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
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