top of page
Laboratory Medicine
FDA permits marketing of artificial intelligence-based device to detect certain diabetes-related eye problems

Written by: Levan Iashvili


The U.S. Food and Drug Administration  permitted marketing of the first medical device to use artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy in adults with diabetes. Diabetic retinopathy occurs when high levels of blood sugar lead to damage in the blood vessels of the retina. 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.  IDx-DR is the first device authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results, which makes it usable by health care providers who may not normally be involved in eye care.

bottom of page