FDA has given a nod to yet another artificial intelligence (AI)-based technology. This time the agency has granted a De Novo request to market IDx’s AI-based diagnostic system for the autonomous detection of diabetic retinopathy, which can lead to blindness. The Coralville IA-based company’s IDx-DR diagnostic received expedited review under the FDA's Breakthrough Devices program.
Earlier this year, the company met its endpoints in a pivotal trial of the IDx-DR system. The trial involved 900 diabetes patients at 10 sites. The study was designed to evaluate the diagnostic accuracy of the technology in detecting moderate to severe diabetic retinopathy, including macular edema. The results of the pivotal trial met the study hypotheses that were developed in consultation with FDA and demonstrated the IDx-DR system exceeded these performance goals. The IDx-DR solution involves a small robotic camera that takes images of the eye. An AI algorithm then analyzes the image taken from the camera of the patient’s retina and helps to make a determination if a diabetes patient is suffering from retinopathy.
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, said Malvina Eydelman, 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 use of AI is undoubtedly on the rise in healthcare. From fledging MedTech companies to established giants like Watson IBM— many firms are riding the current AI wave. – MDDI Online