The FDA cleared the first medical device to use artificial intelligence to measure eye disease diabetic retinopathy in diabetic adults.
The condition, caused by high blood sugar levels damaging retinal blood vessels, is the most common cause of vision loss among diabetics and the leading cause of blindness among working-age adults.
The device uses AI software to analyze images of users’ eyes taken with retinal cameras. A doctor uploads the photos to a cloud server, after which the software can diagnose diabetic retinopathy.
It is the first FDA-authorized device that provides a screening decision without the need for a clinician’s opinion, so doctors who do not normally provide eye care could potentially use it.
The clearance “permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office,” said Malvina Eydelman, director of CDRH’s Division of Ophthalmic and Ear, Nose and Throat Devices.
The FDA based its clearance on a clinical study of 900 patients at 10 primary care sites that found the device correctly identified the presence of retinopathy 87.4 percent of the time. — Zack Budryk