The FDA on April 11 approved IDx to market IDx-DR, a medical device that uses artificial intelligence to detect diabetic retinopathy.
To use the IDx-DR software, a provider uploads digital images of a patient's eyes — taken with a specialized retinal camera — to a cloud server. On the server, IDx-DR applies an AI algorithm to analyze the images and determines whether the patient has more than a mild case of diabetic retinopathy.
Diabetic retinopathy, a diabetes-related eye disease, is the most common cause of vision loss among diabetes patients in the U.S.
If the software detects more than mild diabetic retinopathy, it suggests referring the patient to an eye care professional for more in-depth diagnostic evaluation. If IDx-DR does not detect the condition, it recommends the diabetes patient undergo a routine rescreen in 12 months.
This approval marks the first medical device the FDA has authorized to provide a screening decision without requiring a specialist to interpret the results. For IDx-DR, the approval means providers who aren't typically involved in eye care — such as primary care physicians — are still able to use the device.
"Many patients with diabetes are not adequately screened for diabetic retinopathy since about 50 percent of them do not see their eye doctor on a yearly basis," explained 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.
The FDA reviewed IDx-DR under its De Novo premarket review pathway, which is targeted toward "novel" low- to moderate-risk medical devices, the FDA noted in an April 11 statement. To evaluate IDx-DR, the FDA reviewed data from a clinical study of 900 patients with diabetes across 10 primary care sites. IDx-DR accurately identified the presence of diabetic retinopathy 87.4 percent of the time, and accurately identified those without the disease 89.5 percent of the time.
In a series of tweets April 11, FDA Commissioner Scott Gottlieb, MD, wrote the agency is working toward a new regulatory approach to review AI algorithms that diagnose and treat diseases.
"[The] FDA is taking steps to promote innovation and support the use of artificial intelligence based medical devices," he wrote. "We're working with providers and consumers to address technology & safety questions re: continuous learning AI."