FDA OKs Fully Autonomous AI for Portable Diabetic Retinopathy Screening

AEYE Health, a company focused on artificial intelligence (AI) retinal imaging and diagnostics, has obtained U.S. Food and Drug Administration (FDA) clearance for a fully autonomous AI that diagnoses referable diabetic retinopathy from retinal images taken by a handheld camera.
 
The FDA clearance is the first of its kind. The company said combining a fully autonomous AI with a portable, handheld device welcomes a new, affordable screening solution to address the leading cause of blindness in the working ago. The solution is especially suited for point-of-care screening in both the clinic and at home.
 
AEYE Diagnostic Screening technology (AEYE-DS) is already FDA-cleared and commercially available with a tabletop imaging device. It now holds the merit of the first, only AI solution for autonomous screening anywhere by using the Optomed Aurora portable, handheld device. AEYE-DS, according to the company, is also the only solution that screens patients with only one image per eye with over 99A% imageability.
 
The new FDA nod is based on two large-scale, prospective phase-III studies. In these studies, AEYE-DS showed best-in-class efficacy and imageability: Diagnostic sensitivity was in the 92-93% range and specificity was in the 89-94% range. More than 99% of patients received a diagnostic result in both studies. The AI produced diagnostic results using a single image from each eye, rarely requiring dilation.
 
AEYE Health co-founder and CEO Zack Dvey-Aharon, Ph.D. called AEYE-DS 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.
 
“In the coming years our fully-autonomous screening technology will become standard across points of care in the U.S.,” Dr. Dvey-Aharon said. “We believe this innovation will prevent the blindness of millions of people in the US and around the world. 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.”
 
Dr. Tsontcho (Sean) Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board member of AEYE Health, called AEYE’s FDA nod the most exciting clearance seen in recent years. He said the meaningful and impactful innovation extends not only to the tech and clinical care front, but also population health.
 
“A simple click without dilation right when you visit your primary care doctor, at the pharmacy or even at home, can instantly inform you about diabetic retinopathy,” Dr. Ianchulev told the press. “This can streamline care, reduce patient burden, and ultimately ensure exponential access to essential sight-saving service. Earlier systems have struggled because of efficacy, throughput, imageability, portability and need for dilation but we see a major leap forward technologically with this holy grail system that really has it all.”