IDx-DR is claimed to be the first medical device to use AI for detecting greater than a mild level of the eye disease, diabetic retinopathy, in adults who have diabetes.
IDx-DR is a software program, which uses an AI algorithm to study images of the eye taken with a retinal camera known as the Topcon NW400.
A doctor will upload the digital images of the patient’s retinas on a cloud server with IDx-DR software.
If the images are of enough quality, the software offers the doctor with one of two results, including more than mild diabetic retinopathy detected: refer to an eye care professional or negative for more than mild diabetic retinopathy; rescreen in 12 months.
If a positive result is observed, patients need to contact eye care provider for further diagnostic assessment and possible treatment.
FDA approved the device based on the data from a clinical study of retinal images generated from 900 patients with diabetes at 10 primary care sites.
The study has been designed to assess how often IDx-DR can accurately detect patients with more than mild diabetic retinopathy.
According to FDA, IDx-DR was able to correctly identify the presence of more than mild diabetic retinopathy 87.4% of the time in the study, and was able to correctly identify those patients who did not have more than mild diabetic retinopathy 89.5% of the time.
FDA Center for Devices and Radiological Health’s ophthalmic, and ear, nose and throat division director Dr Malvina Eydelman said: “Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office.”
“The FDA will continue to facilitate the availability of safe and effective digital health devices that may improve patient access to needed health care.”
Image: FDA has IDx-DR medical device to detect certain diabetes-related eye problems. Photo: courtesy of IDx LLC.
