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.

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

FDA recently issued two draft guidance documents discussing: (1) the use of artificial intelligence (AI) to produce information to support ...

Artificial Intelligence (AI) has transformed various industries, and healthcare is no exception. Among the many advancements, ...

Philips’ Shez Partovi said a lot of the company's focus is working to determine how AI can be used to give time back to ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

Could artificial intelligence replace a visit to your doctor? KYW medical editor Dr. Brian McDonough looks at research from ...

In today’s digital age, the United States’ technological competitiveness holds a pivotal position on the global stage. Behind ...

KFDA sets global standard for generative AI medical device approval guidelines Health authority introduces pioneering ...

Wearable devices can identify, differentiate, and predict flare-ups, or the worsening of symptoms and inflammation, in inflammatory bowel disease (IBD), Mount Sinai researchers have shown in a ...

It's been over a decade since the Fitbit was first introduced, and more companies have entered the market for wearable health ...