U.S. FDA approves AI device to detect diabetic eye disease

The device, called IDx-DR and produced by Iowa-based IDx LLC, is the first to receive Food and Drug Administration authorization that provides a screening decision without need for a clinician to also interpret the image or results. That makes it usable by health care providers not normally involved in eye care, such as primary care physicians who interact far more frequently with patients with diabetes. It was reviewed under new FDA regulations designed to speed to market some devices seen as low- to moderate-risk and for which there is no prior legally marketed device, part of Commissioner Scott Gottlieb's efforts to streamline approvals on a variety of fronts, including generic drugs and cheaper versions of costly biotech medicines. "The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care," Malvina Eydelman, who oversees the agency's division of ophthalmic, and ear, nose and throat devices, said in a statement. IDx-DR will be used to detect diabetic retinopathy, in which high levels of blood sugar lead to damage in the blood vessels of the retina and vision loss.