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 standard.
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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.
Read →295 New AI Devices Authorized in 2025
The FDA authorized 295 new AI/ML-enabled medical devices in 2025 — a record year.
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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 III — triggering conformity…
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