AI in Healthcare

The latest on artificial intelligence transforming medicine

News stories discovered, structured, and analyzed by LLMs. Covering clinical deployments, research breakthroughs, regulation, and industry developments.

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regulationQuickbird Medical

EU AI Act: New Compliance Guidelines for Medical Device Manufacturers Take Shape

As the EU AI Act's high-risk requirements approach their August 2026 enforcement date, detailed guidelines for medical device manufacturers clarify how AI Act obligations interact with existing EU MDR requirements.

EUAI-ActMDRmedical-devices
regulation

FDA Reduces Oversight of AI Health Software and Wearables, Clarifying Low-Risk Categories

The FDA published guidance in January 2026 that reduces regulatory oversight of certain AI-enabled health software and consumer wearables, clarifying that many low-risk tools fall outside medical device regulation when clinicians can independently review recommendations.

Telehealth.org
FDAregulationdigital-health
regulation

2025 Year in Review: 295 AI/ML Medical Device Clearances Set New Record

The FDA cleared 295 AI/ML-enabled medical devices in 2025, bringing the cumulative total past 1,200. Radiology continues to dominate, but cardiology and pathology AI tools are growing rapidly.

Innolitics
FDAmedical-devices510k

How this works

Discover

An automated pipeline searches the web for significant AI healthcare news across clinical, research, regulatory, and industry domains.

Structure

Claude analyzes each source, extracts key information, and produces structured articles with categories, tags, and analytical context.

Publish

Stories are deduplicated, stored, and published to this site. The pipeline runs automatically to keep coverage current.