In the EU, the AI Act has been approved, carrying significant implications for medical device, technology, and pharmaceutical firms. In the US, ...

The FDA is particularly concerned that supply chain issues are having an adverse impact on neonatal and paediatric patients.

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

As AI in the medical device space rises, it likely means 2025 will be another challenging year for cyber threats in ...

The U.S. Food and Drug Administration has pulled draft guidance from its website requiring companies to test medicines and ...

FDA faces radical changes under Trump, risking public health and regulatory stability. • Trump reinstates the “Schedule F” order, threatening federal employees’ job security and increasing political ...

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

Medtech supplier Cortland Biomedical said the new designation positions it as a full-service contract manufacturer.

The Trump administration tapped Sara Brenner, a career FDA official, to serve as the acting commissioner of the agency.

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