This article explores the global regulatory landscape, examining how leading authorities in the U.S., EU, U.K., Canada, China ...

AI is a transformational force in healthcare, but without cybersecurity as its foundation, it becomes a high-stakes gamble.

The question is not whether AI will transform healthcare; it’s whether regulators can keep pace with that transformation.

Trump administration policies have raised questions about how the FDA will regulate AI in medical devices. AdvaMed board ...

The rise of AI in health care presents new challenges related to the patentability and regulation of AI-driven medical ...

AI-powered, internet-connected medical devices have the potential to revolutionize health care by enabling early disease detection, real-time patient monitoring, and personalized treatments ...

From mere manufacturing, this region is now looking to spearhead the latest growth and developments in medical technology.

Since 2016, the average number of medical AI device authorizations by the FDA per year has increased from two to 69, ...

The medical field has always been a beacon of innovation, and the integration of artificial intelligence (AI) has supercharged advancements, particularly through the convergence of devices ...

From tumor-detecting software in radiology to digital therapy support, artificial intelligence opens up a wide range of possibilities for making medical devices more efficient and patient-oriented.

But Europe is moving ahead with its plans to enforce its AI Act starting 16 months from now anyway, our Claudia Chiappa reports. Medical devices with AI components that are classified as high risk ...

Experienced medical device engineer and researcher Sai Teja Nuka suggests that these critical processes can be streamlined by implementing an innovative AI-driven approach, enhancing regulatory ...