FDA Readies to Regulate AI and Machine Learning in Medical Devices

Updated

The U.S. Food and Drug Administration has set its sights on the issue of artificial intelligence and machine learning in medical devices. Experts now say that the agency will need to open up a specific regulatory pathway for these devices that is sensitive to the unique risks and benefits posed by this technology and its possible impact on the practice of medicine. 

Continual learning, also known as “continuous” or “lifelong” learning, is an artificial intelligence technique through which mathematical models remain adaptive to the external world. Mathematical models are able to evolve by continuously incorporating new information based on real world feedback without losing previously learned knowledge, which can make its decisions more adaptive to the outside world in a similar manner to how human and animal minds acquire new insights. Researchers have anticipated the ability of these techniques to advance outcomes in medicine because of the potential it carries for automation, accuracy, and objectivity. 

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