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

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 ...

The FDA’s Breakthrough Device Designation is reserved for medical ... of cutting-edge generative and agentic AI technologies. By combining expertise in artificial intelligence and pathology ...

Modella AI, a pioneer in generative and agentic artificial intelligence for biomedicine, is proud to announce that its ...

Living intelligence systems can sense, learn, adapt and evolve through the use of AI, advanced sensors and biotechnology, and ...

Generative artificial intelligence (GenAI) is rapidly transforming various sectors, including healthcare and education. This paper explores the potential opportunities and risks of GenAI in graduate ...

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

Modella AI, a pioneer in generative and agentic artificial intelligence for biomedicine ... The FDA's Breakthrough Device Designation is reserved for medical devices that offer significant ...

Medical devices are revolutionizing healthcare. These devices improve patient outcomes, from tracking and recording vitals to measuring glucose levels to supporting cardiac conditions. The future ...