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.

Filtered by: medical-devicesClear filter
regulationEuropean Commission

EU Clarifies That High-Risk AI Rules Will Hit Many Medical Devices Later Than 2026

Updated European Commission guidance on the AI Act makes clear that many AI systems embedded in regulated products such as medical devices are classified as high-risk, but their specific obligations are set to apply from August 2, 2027. The timing matters for manufacturers trying to map MDR, product liability and AI Act requirements into one compliance strategy.

EU-AI-Actmedical-devicescomplianceEHDS
regulation

FDA Clears eMurmur’s New AI Heart-Murmur Detection Software

eMurmur received FDA 510(k) clearance for eMurmur Heart AI (2.2), a next-generation heart-murmur detection platform designed for use with digital stethoscopes. The authorization is a concrete reminder that AI device innovation is spreading beyond radiology into frontline physical-exam workflows.

MassDevice
FDAmedical-devicesdiagnostics
regulation

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.

Quickbird Medical
EUAI-ActMDR
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

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