FDA is permitting marketing of the first medical device that uses artificial intelligence to detect greater than a mild level of the eye disease diabetic retinopathy.
IDx-DR (IDx LLC), a software program that uses an artificial intelligence AI) algorithm to analyze images of the eye taken with a retinal camera, 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, FDA said in a statement. That capability makes it usable by healthcare providers who may not normally be involved in eye care.
Diabetic retinopathy is the most common cause of vision loss among the more than 30 million Americans living with diabetes and the leading cause of vision impairment and blindness among working-age adults.
“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes, yet many patients with diabetes are not adequately screened for diabetic retinopathy since about 50% of them do not see their eye doctor on a yearly basis,” said Malvina Eydelman, MD, director of the Division of Ophthalmic, and Ear, Nose and Throat Devices at the FDA's Center for Devices and Radiological Health. “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”
Here’s how the AI device works: 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.
FDA evaluated data from a clinical study of retinal images obtained from 900 patients with diabetes at 10 primary care sites. In the study, 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.
IDx-DR was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development, to expedite evidence generation and the agency’s review of the device.