FDA allows marketing of IDx-DR artificial intelligence device for diabetic retinopathy detection

The FDA has permitted the marketing of IDx-DR, the first artificial intelligence medical device to detect more than a mild level of diabetic retinopathy in adults with diabetes, according to a press release.

IDx-DR (IDx LLC), a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with the Topcon NW400 retinal camera, is the first device authorized for marketing that provides a screening decision without a clinician having to interpret results, the release said.

It provides doctors with two results, either positive for more than mild diabetic retinopathy or negative for more than mild diabetic retinopathy. If a positive result is detected, patients should be referred for further diagnostic evaluation and treatment.

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% of them do not see their eye doctor on a yearly basis,” Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, said in the release.