FDA Approves Unique Device for Diabetic Retinopathy Screening

This is the first device authorized for marketing that provides a screening decision without the need for clinician interpretation.

The Food and Drug Administration (FDA) has granted marketing clearance to IDx-DR (IDx LLC), the first artificial intelligence (AI)-based medical device to detect greater than a mild level diabetic retinopathy in adults with diabetes.

IDx-DR is a software program with an AI algorithm to analyze images of the eye taken with the Topcon NW400 retinal camera. The physician uploads the patient’s retinal images to a cloud server where the IDx-DR software is installed. Once the images are uploaded, the software indicates 1 of 2 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.” Following a positive result, the patient should be referred to a specialist for further diagnostic evaluation and treatment. 

The FDA’s authorization marks IDx-DR as the first device to provide a screening decision without requiring the clinician to also interpret the results. The IDx-DR is only intended to detect diabetic retinopathy, including macular edema. It should not be used to detect any other disease or condition. In addition, patients with certain conditions (i.e., persistent vision loss, blurred vision, floaters, previously diagnosed macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, retinal vein occlusion) or those with a history of laser treatment, surgery or injections in the eye should not be screened with IDx-DR.

IDx-DR was evaluated in a clinical study involving retinal images from 900 patients with diabetes to determine how often IDx-DR could accurately detect patients with greater than mild diabetic retinopathy. The data showed IDx-DR correctly detected the presence of more than mild diabetic retinopathy 89.5% of the time. 

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“Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office. The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care,” said 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.

For more information visit FDA.gov.