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FDA Approves First Medical Device To Use Artificial Intelligence For Diabetic Patients

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The first medical device to use artificial intelligence in detecting diabetic retinopathy is coming soon in the market after getting an approval from the U.S. Food and Drug Administration.

The device is significant in early detection of retinopathy, the common cause of blindness among the more than 30 million adults with diabetes. This disease is also the leading cause of vision impairment among working-age adults.

First Device Without The Need For A Clinician

The AI will solely interpret the image acquired by the IDx-DR device. It eliminates the intervention of specialists for less pertinent cases while also allowing more health care providers to attend when a case warrants immediate attention.

IDx-DR is designed with a software algorithm compatible with a retinal camera called the Topcon NW400. The attending physician will just need to upload the software to a cloud server and subsequently, the digital images of patient's retinas. It will automatically retrieve one of two recommendations: more than mild diabetic retinopathy detected: refer to an eye care professional or negative for more than mild diabetic retinopathy; rescreen in 12 months.

Before giving the green light, the FDA conducted a clinical study of retinal images from 900 diabetic patients. The study evaluates how the IDx-DR can accurately interpret the images.

The device yielded precise interpretations 87.4 percent of the time for patients with mild diabetic retinopathy. It was also an accurate 89.5 percent of the time in saying that patients are negative for the condition.

IDx-DR Is Integral For Early Detection Of Diabetic Retinopathy

According to the National Eye Institute, diabetic retinopathy sometimes results in irreversible vision loss. Hence, timely medical intervention can significantly diminish blindness by 95 percent.

"Early detection of retinopathy is an important part of managing care for the millions of people with diabetes," explains Malvina Eydelman, M.D., director of the Division of Ophthalmic, and Ear, Nose, and Throat Devices at the FDA's Center for Devices and Radiological Health.

Eydelman adds that the condition worsens for 50 percent of the diabetic patients because they fail to consult their eye doctor at least once a year.

According to the American Diabetes Association, 7.2 million Americans out of the 30.3 million adults with diabetes remain undiagnosed. The association also notes that 23.1 million were diagnosed with the disease and an additional 1.5 million new cases appear yearly.

Diabetes is the seventh leading cause of death in the United States since 2015. The year alone saw 79,535 death certificates indicating diabetes as the primary cause of death. A total of 252,806 death certificates state that diabetes is both the primary and contributing factor.

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