AI Device for Diabetic Retinopathy Receives FDA Approval

The first-ever medical device to use artificial intelligence (AI) for detecting diabetic retinopathy has received marketing approval from the US Food and Drug Administration (FDA). The AI-based diagnostic system named IDx-DR, which has been developed by privately-held AI diagnostics company IDx (Coralville, IA, USA), is the first device to be authorized for marketing that provides a screening decision without the need for a clinician to also interpret the image or results. This means that the device can also be used by health care providers who may not normally be involved in eye care.

IDx-DR is a software program that uses an AI algorithm to analyze images of the eye taken with a retinal camera named Topcon NW400. A doctor can upload digital images of a patient’s retinas to a cloud server on which the 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.” In a study by the FDA, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4% of the time and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5% of the time.


“The FDA’s authorization to market IDx-DR is a historic moment that has the potential to launch a transformation in the way US healthcare is delivered,” said Dr. Michael Abràmoff, MD, PhD, founder and president of IDx. “Autonomous AI systems have massive potential to improve healthcare productivity, lower healthcare costs, and improve accessibility and quality. As the first of its kind to be authorized for commercialization, IDx-DR provides a roadmap for the safe and responsible use of AI in medicine.”

Related Links:
IDx