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.
Revolutionizing eye health
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.”