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...