21st Century Cures Act driving FDA changes


The Food and Drug Administration last year approved its first autonomous, artificially intelligent medical device. In a decision that seemed to take a page from science fiction, the FDA gave the OK to the IDx-DR, a device that uses artificial intelligence to analyze images of the back of a patient's eye to detect if they have diabetic retinopathy. It's the first FDA-approved device to provide a screening decision without requiring a clinician to interpret the results--which means providers who aren't eye specialists, such as primary-care physicians, can rely on it to screen for the eye disease. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary-care doctor's office," Dr. Malvina Eydelman, director of the division of ophthalmic and ear, nose and throat devices at the FDA's Center for Devices and Radiological Health, said at the time. "The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed healthcare," she added.

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