U.S. officials are warning about a potentially life-threatening issue with smartphone apps that help manage diabetes. The ...

Medical and Healthcare Products Regulatory Agency (MHRA) has released new guidance to help manufacturers meet UK medical ...

Several executive orders recently signed by US President Donald Trump may have significant implications for the US Food and Drug Administration ...

The FDA’s framework for AI regulation, while robust for premarket evaluation, would benefit from more specific mechanisms for continuous monitoring of AI performance in diverse real-world settings.

What will the industry face or achieve in 2025? These trends will be critical in medical device cybersecurity.

As medical devices become more complex, and as regulatory requirements become more rigorous, it’s imperative that medical devices using electronic components are developed as efficiently as possible.

"There is no specific provision for regulation of refurbished medical devices under Medical Devices Rules 2017. Hence no licence is issued for import of such devices and it cannot be imported into the ...

A European Union probe into China’s procurement of medical devices confirmed the bloc’s concerns that the Asian country discriminates against foreign firms, opening the door to potential ...

The Boston health system reprocesses some devices used in its ... and Drug Administration implemented regulations in the early 2000s. Beth Israel Deaconess Medical Center began by reprocessing ...

with certain purposes and functions falling outside of FDA product regulation. Further, when AI/ML based software satisfies the definition of a medical device, is one for which FDA requires ...

BRUSSELS, Jan 14 (Reuters) - EU medical device suppliers are not given fair access to China's public tenders, the European Commission concluded on Tuesday, a finding that could lead to ...