The U.S. FDA has permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes. In fact, the device, called IDx-DR, is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results.
“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,” says 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.
“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care,” Eydelman adds.
Moreover, IDx-DR is a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. A physician uploads the digital images of the patient’s retinas to a cloud server on which IDx-DR software is installed. If the images are of sufficient quality, the software provides the doctor with one of two results: (1) “more than mild diabetic retinopathy detected: refer to an eye care professional” or (2) “negative for more than mild diabetic retinopathy; rescreen in 12 months.”