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First AI-based device for detecting diabetes-related eye conditions gets FDA nod

The US Food and Drug Administration (FDA) has permitted marketing of a medical device that utilizes artificial intelligence (AI) to detect certain eye problems related to diabetes. It is the first device of its kind to harness AI to detect diabetic retinopathy considered greater than a mild level in adult patients with diabetes. 

Malvina Eydelman, MD, director of the Division of Ophthalmic, Ear, Nose and Throat Devices at the FDA’s Center for Devices and Radiological Health, explained as many as half of all diabetic patients do not visit an eye doctor on a yearly basis, so do not receive sufficient screening for diabetic retinopathy. 

“Early detection of retinopathy is an important part of managing care for the millions of people with diabetes… Today’s decision permits the marketing of a novel artificial intelligence technology that can be used in a primary care doctor’s office,” she stated. 

The IDx-DR device uses an AI algorithm to analyze images of the eye taken with the Topcon NW400 retinal camera. Images are uploaded to a cloud server with the IDx-DR software, which can provide doctors with one of two results. Either the patient is cleared with a “negative for more than mild diabetic retinopathy; re-screen in 12 months”, or it returns “more than mild diabetic retinopathy detected: refer to an eye care professional”. 

It is the first device to provide a screening decision without the need for a clinician to interpret the image or results, which means it can be utilized by healthcare providers who may not typically be involved in eye care. The FDA decision was based on a clinical study of retinal images from 900 patients with diabetes. The software was able to correctly identify the presence of more than mild diabetic retinopathy in 87 percent of cases. 

Among those who should not be screened using this technology are patients with a history of laser treatment, surgery or injections in the eye, as are patients with persistent vision loss, blurred vision, floaters, macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.

Earlier this year, analysis conducted by researchers in Sweden suggested diabetes categorizations should be expanded from type 1 and type 2 diabetes to five different forms of the condition. One subgroup, dubbed severe insulin-deficient diabetes, was found to have a significantly higher risk of diabetic retinopathy. 

Diabetic retinopathy is a progressive disease of the retina and it can lead to poor vision, blindness and other complications. There is no cure, but early diagnosis and laser treatment can prevent vision loss. Other treatment options include injections with steroids or anti-VEGF medication, such as Lucentis (ranibizumab). Lucentis works by slowing the growth of abnormal new blood vessels in the eye and decreases leakage from these blood vessels.