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 ...

Here are three recent recalls reported to the FDA: ...

In 2023, the Food and Drug Administration (FDA) took a more active approach to medical device cybersecurity. They issued new requirements for premarket submission and ongoing monitoring by medical ...

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...

The FDA warned the nation about the growing vulnerability of the medical device supply chain and its effects on public health, particularly among pediatric patients, in a Jan. 16 news release.

FDA Medical Device Regulation Over the Use of AI in ... indications that certain participants have a disease state; or (ii) a classification of the severity of participants’ disease state ...

It is not alone, as other health systems discover that reprocessing single-use medical devices can be a win-win for finances ...

Discover the latest FDA-cleared orthopedic and spine devices and technologies, including robotics, implants, and bone graft systems.