The U.S. Food and Drug Administration has qualified the first artificial intelligence tool designed to help doctors assess a ...

FDA sought policy recommendations on mental health medical devices, including AI-enabled. After I reviewed submissions, one ...

Learn more about how the Food and Drug Administration is using agentic AI to assist with safety reviews and inspections.

The FDA has qualified its first artificial intelligence tool to help drug developers evaluate fatty liver disease in their ...

The agency’s sweeping rollout and staff challenge underscore rising momentum behind agentic AI: advanced, multiagent systems ...

The AHA is calling for a framework that balances innovation with appropriate safeguards to protect privacy and patient safety ...

The drive to roll out AI comes after sweeping job losses at the FDA that resulted from the cost-cutting drive implemented by ...

NASH, has received FDA approval to revolutionize liver disease drug trials. This innovative technology assists pathologi ...

FDA announced on Dec. 1, 2025 that it will be providing agency staff with agentic artificial intelligence (AI) capabilities ...

PathAI, a global leader in AI-powered pathology, today announced that the U.S. Food and Drug Administration (FDA) has ...

Resmed (NYSE: RMD) announced today that it received FDA clearance for its Smart Comfort personalized therapy comfort settings ...

The FDA has qualified the first AI-based tool that can be used in clinical trials involving patients with metabolic ...