The advent of artificial intelligence (AI) at the US Food and Drug Administration (FDA) is changing the complexion of the regulatory approval process for medical devices.

Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is ...

Numerous medical devices sold in the United States are subject to active recalls. If you have a medical device that is ...

The Food and Drug Administration has identified a Class I recall of Edwards Lifesciences OptiSite Arterial Perfusion Cannula ...

A dozen lawsuits have been filed over spinal cord stimulators, which are medical devices surgically implanted to reduce chronic back pain. The suits name device manufacturers, such as Abbott and ...

Federal officials said a psychoactive ingredient in kratom had been refined and added to supplements that could quickly ...

A huge drug trafficking operation has been dismantled with two people behind bars after tip-offs led to a house being raided ...

Johnson & Johnson’s Ethicon unit has corrected disposable surgical stapler cartridges over a fault related to one death and one injury, the Food and Drug Administration said Friday.

OraSure Technologies trades near cash value with minimal debt, reflecting excessive market pessimism. Read why I rate OSUR ...

The Ministry of Health, Health Sciences Authority (HSA) and People's Association have launched a campaign encouraging vape ...

SaveHealth reports migraines are complex neurological conditions affecting over a billion globally, requiring comprehensive ...