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.

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: ...

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

AI-Powered Imaging Technologies: he new MRI system utilizes BlueSeal magnet technology, which significantly reduces the need ...

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

The Food and Drug Administration (FDA) has recently issued two draft guidance documents aimed at providing recommendations for the use of AI ...

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

Hospitals across the country are using artificial intelligence. See how guardrails vary from location to location.

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 ...

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

A new peer-reviewed paper from experts at the Oxford Internet Institute, University of Oxford, highlights the need for a clear framework when it comes to AI research, given the rapid adoption of ...