AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.

The FDA has rehired at least some workers tasked with releasing public records generated by the agency’s regulatory ...

Neuralink has received the U.S. Food and Drug Administration's "breakthrough" tag for its device to restore communication for ...

FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.

The apparent reversals are the latest examples of the haphazard approach to agency cuts that have shrunk FDA’s workforce by ...

Neuralink said on social media that it received FDA breakthrough device designation for treating individuals with severe ...

Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.

This marks the latest recall-related issue for HeartMate in recent years. Last June, the FDA deemed another recall as serious ...

Omniasecure, which was authorized for placement in the heart’s right ventricle, is the world’s smallest defibrillation lead, ...

U.S. Food and Drug Administration approvals of life-changing, high-risk medical devices reportedly slowed to a 10-year low for the January to March period, as sources say recent layoffs have had ...