AI For Diabetic Retinopathy Screening Gets U.S. FDA Approval – Forbes

AI-based retinal imaging and diagnostics startup AEYE Health announced today it received clearance from the FDA to market its diagnostic screening system for diabetic retinopathy.
Diabetic Retinopathy.
There are 35 million diabetics in the U.S. and over 420 million worldwide who are at risk of developing diabetic retinopathy requiring an annual screening. Early diagnosis and intervention are key for sight-loss prevention. While more than 90% of vision loss caused by diabetes can be avoided with early detection and treatment, an estimated 60% of people with diabetes in the U.S. find themselves unable to obtain annual eye exams.
The AI model developed by AEYE Health goes beyond just matching what retina specialists do, expanding the diagnostic capabilities currently available as it detects signs of diabetes in images that retinal experts deemed healthy. Retina specialists diagnose diabetes from retinal images if the complications associated with diabetes are visible in the images. The AEYE Health AI model, however, can diagnose diabetes from otherwise healthy retinas. This results in the detection of an earlier stage of diabetes, providing an opportunity to receive proper treatment and mitigate complications before they arise.
“This is a huge step in revolutionizing diagnostic screening for diabetic retinopathy. AEYE’s technology delivers the first practical solution, as it features best-in-class efficacy alongside best-in-class usability, having the only one-image-per-eye solution and highest general and dilation-free imageability data,” Zack Dvey-Aharon, Ph.D., CEO of AEYE Health, said in a statement.
Earlier this year, AEYE Health reported the results of a first-of-its-kind clinical trial to evaluate whether AI software can accurately detect more-than-mild diabetic retinopathy using a single image per eye, obtained from either a desktop or handheld retinal camera. In the study, AEYE Health demonstrated best-in-class clinical efficacy with 93% sensitivity and 91.4% specificity; and streamlined usability for practicable deployment in the primary care channel with single-image non-mydriatic imaging and effective screening in more than 99% of patients.
The AYEYE Health solution requires only a single image per eye which shortens the screening process to one minute and increases its practicality and seamlessness. In addition, it delivers a diagnostic result for patients while rarely requiring dilation, making it the first practical solution for use in primary care settings.
“The time has finally come for autonomous screening technology to exceed the efficacy of the human expert. The implications are that it can be practical for deployment on the front lines of population health – the primary care offices, where 99% non-mydriatic imageability and single image diagnostic acquisition are tantamount to market success, ” said in a statement Dr. Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health.
The vision driving what AEYE Health develops, as Zack Dvey-Aharon’s recently told the Times of Israel, is that in the not-too-distant future, screening for potential loss of sight “will be as easy as walking into a CVS, putting your chin on a chinrest, and learning within seconds if you’re at risk of going blind or not.”
Dr. James Ledwith, assistant professor of Family Medicine and Community Health at UMass, added the perspective of primary physicians: “The use of a compact retinal camera and AEYE Health software in our practice will assure that every patient can be screened during one of their routine visits each year. We anticipate that physicians using this technology will improve screening performance from 30-35 percent to 80 percent or more. When one out of four patients with diabetes has retinopathy, primary care screening will result in new vision-saving intervention.”
Tech is transforming the care and management of diabetes by providing everything from enhanced diagnostics to therapeutic teddy bears, according to CB Insights. Annual healthcare spending worldwide for diabetes reached nearly $1 trillion last year. In the U.S., 25% of all healthcare dollars are spent on caring for diabetes patients, making it the second most expensive chronic disease, just behind heart disease.
The number of U.S. adults living with diabetes totaled 537 million in 2021, a number estimated to rise to 643 million by 2030. Almost 96 million adults in the U.S. have prediabetes and 80% of them don’t even know they have it. Diabetic retinopathy is a leading cause of blindness in American adults and the number of individuals suffering from the disease is projected to reach over 11 million by 2030.
AI-based solutions like the one for diabetic retinopathy screening from AEYE Health promise to both improve the practice and reduce the cost of healthcare.

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