- Federal regulators have given the green light to mHealth technology that can identify diabetic retinopathy in adults without the need for a specialist consult.
The U.S. Food and Drug Administration has cleared the IDx-DR, which uses artificial intelligence tools to screen for a greater than mild level of retinopathy in adults with diabetes. In issuing its approval, the agency said the device can be used by healthcare providers who may not have experience in eye care, such as primary care doctors and those in community health clinics.
"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," 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, said in a press release.
“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office,” she added.
Developed by Coralville, Iowa-based IDx, whose partners include IBM Watson Health, the IDx-DR software screens images taken by the Topcon NW400 retinal camera and uploaded to a cloud server and issues a positive or negative finding for “more than mild diabetic retinopathy.” A positive result includes the recommendation that the patient see an eye care professional.
“The healthcare system desperately needs a more efficient and cost-effective way to detect diabetic retinopathy,” IDx Founder and President Dr. Michael Abràmoff, a retina specialist at the University of Iowa Hospitals & Clinics, said in a press release announcing the FDA’s acceptance of the technology for De Novo review. “Too many patients go blind needlessly because they aren’t diagnosed in time.”
The FDA based its approval on a study of some 900 patients at 10 primary care clinics. According to that study, the IDx-DR software was 87.4 percent successful in identifying more than mild diabetic retinopathy and was 89.5 percent successful in identifying patients whose eye images did not meet that level.
The agency also noted that the technology should not be used on patients with a history of laser treatment, surgery or eye injections, as well as those experiencing persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion. Also excluded are pregnant patients, who may experience a rapid progression of diabetic retinopathy that the technology won’t identify.
The FDA approved the IDx-DR as a Breakthrough Device, “meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device.”
To qualify for that classification, a device “must provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition, and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.”