AEYE Health receives FDA clearance for AI-based autonomous screening for referable diabetic retinopathy
15 Nov 2022
Phase 3Diagnostic Reagents
New technology raises the bar for streamlined primary care screening with best-in-class diagnostic efficacy and breakthrough clinical usability
NEW YORK, Nov. 15, 2022 /PRNewswire/ -- AEYE Health, a leading company for AI-based retinal imaging and diagnostics, is pleased to announce that it received a 510(k) clearance from the U.S. Food & Drug Administration (FDA) to market its diagnostic screening system for diabetic retinopathy.
Over 35M people with diabetes in the US and over 422M worldwide are at risk of diabetic retinopathy, the leading cause of blindness in the working age population. In fact, an estimated 85% of patients with diabetes over the age of 40 will develop diabetic retinopathy. The condition is best diagnosed with a comprehensive eye exam. While more than 90% of vision loss caused by this disease can be avoided with early detection and treatment, the vast majority of people with diabetes in the US find themselves unable to obtain annual eye exams.
Screening diabetics for retinopathy using AI has recently become reimbursable in the United States using the newly approved CPT code 92229 for AI-diagnostic screening.
AEYE's FDA approval is based on pivotal Phase III study results which redefine both efficacy and usability of autonomous screening diagnostics in ophthalmology, which include:
Best-in-class clinical efficacy with
93% sensitivity and
91.4% specificity.
Recognition as the first and
only solution that requires only a single image per eye, which shortens the screening process to one minute and increases its practicality and seamlessness.
Best-in-class imageability, delivering a
diagnostic result for over 99% of patients and rarely requiring dilation.
The technology's accuracy, combined with the need to obtain only a single image per eye and the rare need to dilate, makes AEYE's solution uniquely suited for use in primary care.
The AEYE-DS is indicated for use with images obtained by Topcon NW-400, a leading desktop retinal camera. The company is continuing its work to receive clearance for the first diagnostic screening solution for a portable camera following its pivotal study data announced earlier this year.
Furthermore, the company is advancing a follow-on program for the screening of glaucomatous optic neuropathy where the company recently announced high diagnostic potential with sensitivity of 92.2% and specificity of 92.6% and expects to initiate FDA pivotal trials soon.
"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," says Zack Dvey-Aharon, Ph.D., CEO of AEYE Health. "AEYE is still working to obtain clearance for the first and only diagnostic screening solution with a portable camera. We cannot be more excited to lead the innovation in this space with the goal of saving millions of people from losing their vision".
On the enormous implications following the clearance and in the company's technology, Dr. Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health, says, "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 over 99% imageability and single image diagnostic acquisition are tantamount to market success".
About AEYE Health
AEYE Health is a digital health company that provides fully autonomous, AI-based diagnostic screening solutions for retinal imaging with best-in-class clinical results and superior usability. The company aims to make diagnostic screening practical, accurate and accessible. AEYE Health enables point-of-care screening for diabetic retinopathy to ensure that diabetics are regularly screened for diabetic retinopathy.
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AEYE Health Press Team
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