FDA permits marketing of AI-based device to detect certain diabetes-related eye problems

FDA announced Wednesday has permitted marketing of a medical device, the IDx-DR (from IDx LLC), that uses artificial intelligence to detect more than a mild level of diabetic retinopathy in adults with diabetes.

FDA announced Wednesday has permitted marketing of a medical device, the IDx-DR (from IDx LLC), that uses artificial intelligence to detect more than a mild level of diabetic retinopathy in adults with diabetes. The condition—the most common cause of vision loss among people with diabetes—occurs when high levels of blood glucose lead to damage in the blood vessels of the retina. "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," said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at FDA's Center for Devices and Radiological Health. "Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office." A clinical study of retinal images obtained from 900 patients found that IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4% of the time and was able to correctly identify patients who did not have more than mild diabetic retinopathy 89.5% of the time.