The FDA recently issued the discussion paper “Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD)” and a request for comments.

Commissioner Scott Gottlieb issued a statement at the time of the paper’s release lauding artificial intelligence and machine learning as having “the potential to fundamentally transform the

FDA continues to be active in emphasizing the importance of artificial intelligence in health care. Now, FDA has committed to a program of creating a knowledgeable, sustainable, and agile data science workforce ready to review and approve devices based on artificial intelligence.

In April of last year, FDA Commissioner Scott Gottlieb, in discussing the

A recently published article in Nature Medicine authored by Eric Topol, M.D., Department of Molecular Medicine, Scripps Research Institute, suggests that the convergence of human and artificial intelligence can lead to “high-performance medicine.”  High performance medicine he says, will be data driven.  The development of software that can process massive amounts of information quickly

FDA is taking steps to embrace and enhance innovation in the field of artificial intelligence. It has already permitted the marketing of an AI-based medical device (IDx-DR) to detect certain diabetes-related eye problems, a type of computer-aided detection and diagnosis software designed to detect wrist fractures in adults (OsteoDetect), and most recently, a platform