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

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

For those with Class IIa or above AI-related devices, compliance with the EU’s AI Act is likely to be akin to the EU MDR.

Rahul Saluja, Senior Executive and Thought Leader in Life Sciences.

Ageing patient populations and technological advancements are emerging as key drivers of healthcare innovation and delivery.

Artificial Intelligence (AI) is reshaping the healthcare industry by enhancing medical equipment, improving diagnostic ...

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

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

The MHRA has issued fresh guidance to help medical device manufacturers prepare for upcoming regulatory changes.

You’re reading the web edition of STAT’s Health Tech newsletter, our guide to how technology is transforming the life ...

South Korea’s Ministry of Food and Drug Safety said it released the world’s first guideline on reviewing and approving generative artificial intelligence-based medical devices Jan. 24, to help ...