The Food and Drug Administration has approved the first medical device to use artificial intelligence to detect more than a mild level of diabetic retinopathy in adults who have diabetes—a condition that leads to vision loss for about 24,000 Americans annually.

“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, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health.

Eydelman adds that FDA clearance “permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”

The IDx-DR device is a software program that uses an AI algorithm to analyze images of the eye taken with a specific retinal camera—called the Topcon NW400—and according to the regulatory agency 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, which makes it usable by healthcare providers who may not normally be involved in eye care.”

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The device was reviewed under the FDA’s De Novo premarket review pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device. The agency evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites.

“In the study, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4 percent of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5 percent of the time,” the FDA announcement states.

According to Michael Abramoff, MD, founder and president of IDx, the device is the first autonomous, AI-based diagnostic system authorized for commercialization by the FDA.

“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way U.S. healthcare is delivered,” says Abràmoff. “Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

Abramoff adds that IDx is developing other AI-based diagnostic algorithms for detecting Alzheimer’s disease, cardiovascular disease, glaucoma, macular degeneration and stroke risk.

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