FDA OKs AI Device to Detect Diabetic Retinopathy in Primary Care

Megan Brooks

Disclosures

April 11, 2018

The US Food and Drug Administration (FDA) has cleared the first medical device that uses artificial intelligence (AI) software to detect greater than a mild level of diabetic retinopathy in adults with diabetes and can be used by non–eye care professionals.

The IDx-DR device, from IDx LLC, is the first device authorized for marketing that provides a screening decision without the need for a clinician to interpret the image or results and can be used by healthcare 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, director, Division of Ophthalmic, and Ear, Nose and Throat Devices at 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," Eydelman said.

The IDx-DR device analyzes images of the retina taken with the Topcon NW400 retinal camera. A physician uploads the digital images of the patient's retinas to a cloud server with the IDx-DR software.

If the images are of sufficient quality, the software provides the physician with 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 a positive result is detected, patients should see an ophthalmologist for further diagnostic evaluation and possible treatment as soon as possible, the FDA said.

In approving the device, the FDA reviewed data from a study of retinal images obtained from 900 patients with diabetes at 10 primary care clinics.  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.

According to the FDA, patients with a history of laser treatment, surgery, or injections in the eye or who have any of the following conditions should not be screened for diabetic retinopathy with IDx-DR: persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe nonproliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.

Additionally, IDx-DR should not be used in patients with diabetes who are pregnant because diabetic retinopathy can progress rapidly during pregnancy and IDx-DR is not intended to evaluate rapidly progressive diabetic retinopathy.

IDx-DR had breakthrough-device designation and was reviewed under the FDA's de novo premarket review pathway, a regulatory pathway for some low- to moderate-risk devices that are novel and for which there is no prior legally marketed device.

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