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: device safetyClear filter
technologyEIN News

Cybersecurity keeps sinking FDA submissions, and that should worry every medtech AI team

A cybersecurity executive argues that security failures are now a leading reason FDA medical device submissions get rejected. The warning is especially relevant for AI products, where data flows, connected systems, and software updates widen the attack surface.

cybersecurityFDA submissionsmedtech securityAI risk
regulation

FDA Warning on a Vascular Device After Three Deaths Highlights the Limits of Device Oversight

The FDA’s warning about a vascular device after three deaths is a stark reminder that device safety problems still emerge after products reach the market. In the AI era, it also underscores why post-market surveillance is becoming a central concern for regulators and providers alike.

Cardiovascular Business
FDAdevice safetyvascular device
regulation

FDA Warns Manufacturers on Nitrosamine Impurities as Device Safety Scrutiny Intensifies

The FDA has warned device manufacturers about nitrosamine impurities that could pose cancer risks, broadening a safety issue more commonly associated with drugs. The warning signals that regulators are paying closer attention to manufacturing contaminants and supply-chain quality in medtech.

Medical Design & Outsourcing
FDAdevice safetynitrosamine
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.