More than 30 million Americans live with diabetes, which is the leading cause of Diabetic Retinopathy, the most common cause of vision impairment and blindness among working-age adults. Diabetic Retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina, the light-sensitive tissue in the back of the eye.
In early April 2018 the U.S. Food and Drug Administration (FDA) announced the marketing of the first medical device to use artificial intelligence (AI) to detect greater than a mild level of the eye disease diabetic retinopathy in adults who have diabetes, marking a new era of "diagnosis by software."
According to News Medical Life Sciences, the device, called IDx-DR, is a software program that uses an artificial intelligence algorithm to analyze images of the eye taken with a retinal camera called the Topcon NW400. A doctor uploads the digital images of the patient's retinas to a cloud server on which IDx-DR software is installed. If the images are of sufficient quality, the software provides the doctor with one of two results: (1) "more than mild diabetic retinopathy detected: refer to an eye care professional" or (2) "negative for more than mild diabetic retinopathy; rescreen in 12 months." If a positive result is detected, patients should see an eye care provider for further diagnostic evaluation and possible treatment as soon as possible.