The US Food and Drug Administration permitted the marketing of IDx-DR, a medical device to use artificial intelligence (AI) to detect diabetic retinopathy in adults.
IDx-DR is a software programme that uses an AI 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.”
IDx-DR 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.
Reviewed under the FDA’s De Novo premarket review pathway, IDx-DR was granted Breakthrough Device designation to expedite evidence generation and the agency’s review of the device.