FDA approves artificial intelligence device, first medical device For Diabetic Patients. This is first medical device will be used in detecting diabetic retinopathy is coming soon in the market after getting an approval from the U.S. Food and Drug Administration.
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 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. Then it will refer to an eye care professional or negative for more than mild diabetic retinopathy, and 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.
According to the American Diabetes Association, 7.2 million Americans out of the 30.3 million adults with diabetes remain undiagnosed.