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: postmarket surveillanceClear filter
regulationMSN

FDA Opens a New Front in AI Oversight by Asking Industry How to Monitor Device Safety After Clearance

The FDA is seeking industry feedback on how to monitor AI medical devices after they reach the market, signaling that oversight is shifting from preclearance to lifecycle surveillance. The move reflects a growing recognition that static approval frameworks are not enough for systems that can drift, update, or behave differently in real-world use.

FDAAImedical devicespostmarket surveillance
regulation

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.

Business Wire
FDApostmarket surveillanceadverse events
regulation

FDA recall of Philips Azurion systems puts imaging workflow safety back in focus

The FDA has issued a Class 2 recall for Philips’ Azurion interventional radiology systems, a reminder that software-enabled imaging platforms carry operational risks even when problems stop short of the most severe recall tier. The episode highlights how modern imaging safety increasingly depends on system behavior, workflow design, and postmarket responsiveness rather than hardware alone.

AuntMinnie
FDArecallPhilips

How this works

Discover

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

Structure

The pipeline turns source material into concise, readable stories with categories, tags, and context that make the feed easier to scan.

Publish

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