In a news release, the regulatory body said that it 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." Diabetic retinopathy - which occurs when high levels of blood sugar lead to damage in the blood vessels of the retina - is the leading cause of vision impairment and blindness among working-age adults.
The approved medical 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, says the FDA, which makes it usable by health care providers who may not normally be involved in eye care. IDx-DR is a software program developed by IDx LLC (Coralville, IA) that uses an AI algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400 .
The digital images of a patient's retinas are uploaded to a cloud server on which IDx-DR software is installed. After analysis, the software then provides the doctor with one of two results: "more than mild diabetic retinopathy detected: refer to an eye care professional" or "negative for more than mild diabetic retinopathy; rescreen in 12 months."
"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 percent of them do not see their eye doctor on a yearly basis," says Malvina Eydelman, M.D., 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.”
In coming to its decision, the FDA evaluated data from a clinical study