AEYE Health team (Photo AEYE Health)
AEYE Health, an Israeli firm that develops AI retinal imaging and diagnostics, received the first ever FDA clearance for a fully autonomous AI that diagnoses referable diabetic retinopathy from retinal images obtained by a handheld camera.
AEYE Health said combining a fully autonomous AI with a portable handheld device introduces a new and affordable screening solution to address the leading cause of blindness in the working age. The portable solution is especially suited for point-of-care screening, enabling screenings wherever patients are located – whether in clinic or at-home.
AEYE Diagnostic Screening technology (AEYE-DS) is already cleared by the FDA and commercially available with a tabletop imaging device, and will now become the first and only AI solution to allow autonomous screening anywhere using the Optomed Aurora portable handheld device. AEYE-DS is also the only solution that screens patients using just 1 image per eye with over 99% imageability.
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This new FDA clearance is based on two large-scale prospective phase-III studies, in which AEYE-DS demonstrated best-in-class efficacy and imageability. Diagnostic sensitivity was in the range of 92%-93% and specificity was in the range of 89%-94%. In both studies, over 99% of patients received a diagnostic result. The AI produced its diagnostic results using only a single image from each eye, rarely requiring dilation.
Founded in 2018, AEYE Health is a venture-backed digital health startup that developed AI algorithms that provide immediate, totally autonomous, point-of-care interpretation of fundus images for various conditions. The company’s solutions offer fully autonomous AI-based diagnostic screening with best-in-class clinical results and superior usability. The company engineers its diagnostic screening solutions to be practical, accurate and accessible. Its flagship product AEYE-DS enables point-of-care screening for diabetic retinopathy to ensure that patients with diabetes are regularly screened. Out of the US, AEYE Health provides more than 30 best-in-class AI indications, both sight-threatening and systemic via its AEYE-CS (comprehensive screening) solution.
“This is the ‘holy grail’ of eye screening – fully autonomous AI, using either portable or tabletop retinal cameras and a procedure that takes a minute to perform, alongside the best-in-class diagnostic efficacy,” says Zack Dvey-Aharon, Ph.D., Co-Founder & CEO of AEYE Health. “In the coming years our fully-autonomous screening technology will become standard across points of care in the US. We believe this innovation will prevent the blindness of millions of people in the US and around the world.” Dr. Dvey-Aharon adds: “AEYE keeps working to expand the boundaries of diagnostic screening beyond diabetic retinopathy. Our science is evidently the strongest in this space and we’re proud to make such unbelievable impact.”
