Modern Healthcare September 7, 2019
Jessica Kim Cohen

President Barack Obama signs the 21st Century Cures Act into law on Dec. 13, 2016. The sweeping legislation had broad bipartisan support.

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...

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