AEYE Health, a leader in AI retinal imaging and diagnostics, has announced that it received FDA clearance for the first fully autonomous AI to diagnose referable diabetic retinopathy from retinal images obtained with a handheld camera. This clearance marks a major milestone in making diabetic retinopathy screening more accessible, especially in settings like primary care clinics, pharmacies, and even at home.
The new FDA clearance is based on two large-scale prospective phase-III studies where AEYE-DS, the company’s diagnostic screening technology, demonstrated high diagnostic sensitivity (92%-93%) and specificity (89%-94%). The studies showed that over 99% of patients received a diagnostic result, with the AI producing results using only a single image from each eye, rarely requiring dilation.
This FDA clearance for AEYE-DS brings a portable solution to the field of diabetic retinopathy screening. It is expected to make point-of-care screenings more accessible, addressing the leading cause of blindness in the working-age population. The technology will work with the Optomed Aurora portable handheld device, allowing autonomous screening anywhere, even outside of traditional medical settings.
Dr. Zack Dvey-Aharon, CEO of AEYE Health, commented on the significance of the clearance, stating, “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.”
Revolutionizing eye health
AEYE-DS is already commercially available with a tabletop imaging device and is now the only AI solution to allow portable autonomous screening. The technology also boasts over 99% imageability, an important factor in achieving high-quality diagnostic results.
This new AI-based screening solution holds great importance for public health. It is now reimbursable in the US through the newly approved AI CPT code 92229 for autonomous screening. Additionally, it serves as a major HEDIS measure for most health plans, further highlighting its significance in the healthcare landscape.
Dr. Ianchulev, Professor of Ophthalmology at New York Eye and Ear of Mount Sinai and Board Member of AEYE Health, remarked on the impact of the technology, stating, “This is perhaps the most exciting FDA clearance I’ve seen in recent years. A simple click without dilation when visiting your primary care doctor, at the pharmacy, or even at home, can instantly inform you about diabetic retinopathy. This can streamline care, reduce patient burden, and ultimately ensure exponential access to essential sight-saving service.”
AEYE Health aims to expand the boundaries of diagnostic screening beyond diabetic retinopathy, demonstrating the power of AI in revolutionizing healthcare accessibility and outcomes. The company’s diagnostic solutions are designed to be practical, accurate, and accessible, with over 30 AI indications for sight-threatening and systemic conditions outside the US via its AEYE-CS (comprehensive screening) solution.