FDA developing framework for AI-based medical devices that ‘learn’ in real time

The FDA has announced that it is working toward developing a new regulatory framework for medical devices that use advanced artificial intelligence (AI) algorithms.

“Artificial intelligence has helped transform industries like finance and manufacturing, and I’m confident that these technologies will have a profound and positive impact on health care,” Scott Gottlieb, MD, outgoing FDA commissioner, said in a prepared statement from the agency. “I can envision a world where, one day, artificial intelligence can help detect and treat challenging health problems, for example by recognizing the signs of disease well in advance of what we can do today. These tools can provide more time for intervention,...