When Merdis Wells visited the diabetes clinic at the University Medical Center in New Orleans about a year ago, a nurse practitioner checked her eyes to look for signs of diabetic retinopathy, the most common cause of blindness.
At her next visit, in February of this year, artificial intelligence software made the call.
The clinic had just installed a system that's designed to identify patients who need follow-up attention.
The Food and Drug Administration cleared the system — called IDx-DR — for use in 2018. The agency said it was the first time it had authorized the marketing of a device that makes a screening decision without a clinician having to get involved in the interpretation.
It's a harbinger of things to come. Companies are rapidly developing software to supplement or even replace doctors for certain tasks. And the FDA, accustomed to approving drugs and clearing medical devices, is now figuring out how to make sure computer algorithms are safe and effective.
Wells was one of the first patients at the clinic in early February to be tested with the new device, which can be run by someone without medical training. The system produces a simple report that identifies whether there are signs that a patient's vision is starting to erode.