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: adverse eventsClear filter
regulationBusiness Wire

FDA Turns to AI for Safety Monitoring, Signaling a New Phase in Postmarket Oversight

The FDA’s nationwide adverse event monitoring system is now getting an agentic AI layer, a move that could speed signal detection across devices and drugs. The rollout suggests the agency is increasingly willing to automate parts of its surveillance mission, not just its review workflow.

FDApostmarket surveillanceadverse eventsagentic AI
regulation

New FDA adverse event lookup tool strengthens the infrastructure around medical AI oversight

The FDA’s new adverse event look-up tool is an infrastructure story with outsized implications for AI-enabled medical products. Better visibility into safety signals could improve scrutiny of software-driven devices at a time when adaptive algorithms and faster product cycles are straining traditional oversight methods.

Medical Product Outsourcing
FDAadverse eventsmedical devices

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