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

Health Canada published a regulatory proposal in the Canada Gazette, Part I, Volume 158, Number 52, introducing amendments ...

MDR Certification Strengthens Resyca's Leadership in Soft Mist Drug-Device Combination Products ENSCHEDE, NL / ACCESS Newswire / January 28, 2025 / Resyca BV, a pioneering leader in the development an ...

In the United States, the biomedical industry encounters numerous regulatory challenges in conducting nonclinical and ...

While medical device shortages are nothing new, the FDA said it is becoming more concerned that supply chain disruptions are ...

The new director of the FDA’s device center contrasted a European rule with the lack of mandatory reporting requirements for ...

In its most recent effort to keep pace with advancing technology, the US Food and Drug Administration (FDA) recently issued two draft guidances on ...

New documents clarify how the FDA plans to regulate AI-enabled devices, experts say, but several important questions remain ...

While experts across the political spectrum are generally in favor of stricter regulations ... FDA classifies most beauty products as low risk to health as compared to drugs and medical devices.

By establishing coding and separate payment for certain digital mental health devices, this group from CMS and the FDA hopes ...

Irish neurotech company CergenX has received the Breakthrough Device Designation from the US FDA while being accepted into ...

In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...