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FDA approves IDx’s AI-powered device to detect diabetic eye disease

MDBR Staff Writer Published 12 April 2018

The US Food and Drug Administration (FDA) has approved IDx’s artificial intelligence (AI) powered medical device to detect certain diabetes-related eye problems.

IDx-DR is claimed to be the first medical device to use AI for detecting greater than a mild level of the eye disease, diabetic retinopathy, in adults who have diabetes.

IDx-DR is a software program, which uses an AI algorithm to study images of the eye taken with a retinal camera known as the Topcon NW400.

A doctor will upload the digital images of the patient’s retinas on a cloud server with IDx-DR software.

If the images are of enough quality, the software offers the doctor with one of two results, including 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 a positive result is observed, patients need to contact eye care provider for further diagnostic assessment and possible treatment.

FDA approved the device based on the data from a clinical study of retinal images generated from 900 patients with diabetes at 10 primary care sites.

The study has been designed to assess how often IDx-DR can accurately detect patients with more than mild diabetic retinopathy.

According to FDA, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4% of the time in the study, and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5% of the time.

FDA Center for Devices and Radiological Health’s ophthalmic, and ear, nose and throat division director Dr Malvina Eydelman said: “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.”


Image: FDA has IDx-DR medical device to detect certain diabetes-related eye problems. Photo: courtesy of IDx LLC.