As the threat of counterfeiting continues to torment industry stakeholders and patients, more strategic approaches to ...

There’s no questioning that AI should have governance and guardrails. As much good as it can bring, it also heightens risk.

Pharma: Reform of the EU Pharmaceutical Legislation; German Medical Research Act enacted fostering R&D also including confidentiality of drug ...

We review the Whoop MG, with ECG, blood pressure insights, and a sleek redesign that delivers the deepest health tracking yet ...

Nearly two million people worldwide have lost the simple ability to feel steady. Now researchers have developed an ...

There is a nearly five-year gap between when a new medical device receives FDA approval and is subsequently covered by Medicare.

They are used until they are deemed no longer useful, while humane and more clinically relevant nonanimal methods are often available. But the story of these intelligent animals begins long before the ...

The guidance seeks to help device manufacturers navigate the entire product life cycle concerning AI. The agency's submission comes after a spike in devices set for approval using the technology.

How can physicians and patients be confident enough that vendors entirely ignorant of the FDA process for repair and reporting can properly recalibrate life-saving machines? Is this really the ...

Why it matters: Inclusion of medical devices stands in stark contrast to the historical pattern of strategic exemptions of lifesaving and life-sustaining devices from tariffs.

This narrative review uses the cardiovascular device life cycle as a conceptual framework to enhance understanding and guide future efforts to mitigate disparities in the field of interventional ...