April 12, 2018 -- The FDA has approved the first medical device that uses artificial intelligence (AI) software to detect diabetic retinopathy in adults with diabetes that can be used by non-eye care professionals.
The IDx-DR device interprets results from images it takes and can be used by health care providers who may not normally be involved in eye care, the FDA said in a news release.
"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, of the FDA's Center for Devices and Radiological Health, said in the release.
"Today's decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor's office," said Eydelman, who's director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the center.
The IDx-DR device analyzes images of the retina taken with a retinal camera. A doctor uploads the digital images of the patient's retinas to a cloud server with the device’s software.
The software gives the doctor one of two results: (1) "more than mild diabetic retinopathy detected: refer to an eye care professional" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months."
If the test shows a positive result, patients should see an ophthalmologist for more evaluation as soon as possible, the FDA says.
The FDA reviewed data from a study of retinal images from 900 patients with diabetes at 10 primary care clinics before it approved the device. In the study, IDx-DR correctly identified the presence of more than mild diabetic retinopathy 87.4% of the time and correctly identified patients who did not have more than mild diabetic retinopathy 89.5% of the time.
The FDA says patients with a history of laser treatment, surgery, or injections in the eye, or those who have any of the following conditions, should not be screened for diabetic retinopathy with the IDx-DR: persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe nonproliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.
Also, the device should not be used on patients with diabetes who are pregnant. Diabetic retinopathy can progress rapidly during pregnancy, and the device is not intended to evaluate that type of the disease.