FDA weighs new oversight model for AI medical devices

The FDA has outlined a proposed framework for regulating AI-based software used as a medical device that can continue learning and adapting after reaching the market. The framework centers on what the agency calls a “predetermined change control plan,” which would allow manufacturers to submit an upfront plan describing how an algorithm is expected to […] The post FDA weighs new oversight model for AI medical devices appeared first on Becker's Hospital Review | Healthcare...