AI in Healthcare

The latest on artificial intelligence transforming medicine

News stories discovered and organized by an automated pipeline. Covering clinical deployments, research breakthroughs, regulation, and industry developments.

Filtered by: AI medical devicesClear filter
regulationMSN

FDA Seeks Industry Input on How to Monitor AI Medical Devices After Clearance

The FDA is asking industry how best to monitor AI-enabled medical devices after they are cleared, signaling that post-market surveillance is becoming central to oversight. The move reflects a broader recognition that AI performance can drift over time as data, users, and workflows change.

FDApost-market surveillanceAI medical devicescompliance
regulation

Pediatric AI Devices Remain Rare as Regulation and Data Gaps Slow Progress

AI-enabled medical devices have expanded rapidly in adults, but pediatric products remain a small minority. The imbalance underscores how limited child-specific data, tougher validation requirements, and narrower commercial incentives continue to constrain innovation for younger patients.

Medscape
pediatricsFDAAI medical devices
regulation

FDA’s New Cybersecurity Standard Move Shows AI Medical Devices Will Be Regulated as Connected Systems

The FDA has added AAMI cybersecurity guidance to its recognized consensus standards database, reinforcing cybersecurity as a core expectation for medical devices. For AI-enabled products, the move is a reminder that performance claims alone are no longer enough; secure lifecycle management is becoming part of market access.

TMX Newsfile
cybersecurityFDAAAMI
regulation

Thailand’s Push for International AI Device Standards Reflects a Global Convergence Trend

Thailand is working to ensure AI medical devices align with international standards, signaling how regulators outside the US and Europe are accelerating their frameworks. The move matters because global medtech companies increasingly need interoperable regulatory strategies rather than market-by-market improvisation.

OpenGov Asia
Thailandinternational standardsAI medical devices

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