FDA Approved AI Device for Diabetic Retinopathy Diagnosis


The U.S. Food and Drug Administration (FDA) approved IDx-DR, world’s first medical device operated on Artificial Intelligence that can detect diabetic retinopathy among diabetic patients

Diabetic retinopathy is complicated condition observed in patients suffering from diabetes for a long time. It is a leading cause of vision loss in over 30 million diabetic Americans. The damage caused to the retina is due to the damage of the small blood vessels in the retina that provide the highly sensitive layer with oxygen and nutrients. Without treatment, diabetic retinopathy can lead to a complete loss of vision. Symptoms of retinopathy can result into blindness, although it cannot be reversed, it can be prevented by control of blood sugar and regular screening and early detection.

The new device called IDx-DR uses an Artificial Intelligence algorithm to visualize the images of the retina taken by a camera called the Topcon NW400. The software analyses the uploaded images and provide one of the two responses – more than mild diabetic retinopathy or less than mild retinopathy. If the damage is more than mild, the software advises referral to an eye health professional and if the damage is less than mild, it calls for a rescreening after 12 months. According to the FDA statement, physician can begin treatment as soon as more than mild retinopathy is detected.

As a part of clinical trial, the software successfully detected more than mild diabetic retinopathy in 87.4% cases in around 900 patients who visited 10 primary care sites for diabetes. Furthermore, it also detected mild or less than mild diabetic retinopathy in 89.5% of cases, which proved the efficiency of this software as a diagnostic tool in diabetic retinopathy. However, the device cannot be used for screening in patients suffering from blurring or loss of vision, those who have had eye surgery, laser therapy or eye injections, radiation induced retinopathy, retinal vein occlusion, and macular edema.


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