Artificial intelligence software that can detect diabetes-related damage to the retina — called diabetic retinopathy — has been approved by the U.S. Food and Drug Administration.
The IDx-DR program analyzes images of a patient’s retinas taken with a special camera. The digital images are uploaded to a cloud server on which IDx-DR software is installed.
The software provides one of two results — “more than mild diabetic retinopathy detected: refer to an eye care professional” or “negative for more than mild diabetic retinopathy; rescreen in 12 months.”
If diabetic retinopthay is detected, patients should see an eye care provider for further evaluation and possible treatment as soon as possible, the FDA said.
This is the first approved software that provides a screening decision without the need for a health care provider to interpret the image or results, which means it can be used by health care providers who don’t typically provide eye care.
Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans with diabetes and the leading cause of vision impairment and blindness among working-age adults, according to the FDA.
“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 Dr. Malvina Eydelman, director of the FDA’s Division of Ophthalmic, and Ear, Nose and Throat Devices.
“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office,” Eydelman added in an agency news release.
The FDA said its approval of the software was based on a clinical study of retinal images from 900 patients. IDx-DR correctly identified more than mild diabetic retinopathy 87.4 percent of the time and correctly identified patients who did not have more than mild diabetic retinopathy 89.5 percent of the time.
The software should not be used to screen for diabetic retinopathy in patients who’ve had laser treatment, surgery or injection in the eye or have any of the following conditions: persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy or retinal vein occlusion, according to the FDA.
The agency also said the software should not be used in pregnant women with diabetes because diabetic retinopathy can progress rapidly during pregnancy and the software is not intended to evaluate rapidly progressive diabetic retinopathy.
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