The Food and Drug Administration issued draft guidance Jan. 6 on marketing submissions and lifecycle management for ...

With the FDA's new requirements for premarket submission and ongoing monitoring by medical device manufacturers in place, ...

Source: Authors’ analysis. Medical device recalls are publicly listed on the FDA website, along with the classification of the recall. To elaborate on concerns around clinical utility ...

The task force will help in solving the problems in the approval or registration of stakeholders for medical devices. The FDA will now be able to make the classifications based on the Asean ...

Years of research have showed that pulse oximeters yield less accurate readings for people with darker skin tones, and now ...

Both President Biden, and incoming President Trump, have made AI a top priority, and now the U.S. Food and Drug ...

A Food and Drug Administration (FDA) draft guidance would require manufacturers of pulse oximeters to gather far more ...

The document follows the agency’s first digital health advisory meeting and a final guidance on postmarket updates to AI ...

In a new analysis of AI and ML-enabled devices authorized by the Food and Drug Administration, Brewster and colleagues at Boston Children’s and Harvard Medical School found just that.

While generative artificial intelligence ("GenAI") has the potential to fundamentally change health care, it presents unique risks and ...