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.

A supercapacitor made from sargassum seaweed nanofibers powers medical devices inside the body, kills bacteria, and naturally ...

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

Beta CEO Marcel Botha talks about the FDA’s plans for medical shortage notifications and how Trump’s policies may impact US ...

When conducting a clinical investigation, meeting regulatory requirements is predicated on factors such as the quality of ...

Stryker (NYSE:SYK) reported operating results for the fourth quarter and full year of 2024: Fourth Quarter Results Full Year Results “We delivered another year of double-digit organic sales growth ...

In 2024, as in years past, healthcare fraud enforcement by the U.S. Department of Justice (DOJ) was substantial. Federal actions under the ...

MDR Certification Strengthens Resyca’s Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS ...

Microbot Medical Inc., a Delaware-based company specializing in surgical and medical instruments, announced today that it has regained compliance with Nasdaq's minimum bid price requirement. The ...

HAHN Automation Group is eagerly preparing for the upcoming MD&M West trade show, where we will showcase our state-of-the-art ...

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.