Predetermined Change Control Plans: How AI Devices Update Without a New Clearance
How an FDA PCCP lets an AI medical device update without a new 510(k) or PMA supplement, with planned changes, validation, and…
Read →DEA Telemedicine Prescribing Flexibilities: What Expires and When
DEA telemedicine controlled substance prescribing in 2026: what expires December 31, how Medicare dates differ, and what the rulemaking forecast means.
Read →MDR Plus the AI Act: Why Medical Device AI Is High-Risk by Default
How MDR and AI Act rules make medical device AI high-risk: the two-condition test, Rule 11, notified-body review and what application dates…
Read →FDA Asks for Input on Generative AI Medical Devices Before October 19
FDA generative AI medical device regulation is open for discussion. Learn the risk framework and how to comment by October 19, 2026,…
Read →The EU AI Act Deadline for Medical AI Moved: The New Timeline After the Digital Omnibus
The EU AI Act medical device deadline moves to 2 August 2028 for Annex I high-risk AI. See the revised timeline and…
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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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