Handheld retinal scanner makes vision screening possible for primary care offices

AI Optics Inc., an AI-focused medical device company, announced that it has received FDA 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system designed to improve access to retinal disease screening. The portable device captures high-quality images of the human eye and aims to close critical gaps in screening accessibility caused by specialist shortages, cost, and convenience barriers.

With over one billion people worldwide at risk for retinal diseases, timely detection is vital for preventing vision loss, according to the company. However, many patients face challenges accessing screening due to limited resources. The Sentinel Camera eliminates the need for some patients to visit an eye specialist by offering point-of-care imaging in diverse health care environments, including primary care clinics, retail health settings, and even home health care.

"Early detection of retinal diseases is critical to preserving vision," said Kathryn Colby, M.D., PhD, Chair of the Department of Ophthalmology at NYU Grossman School of Medicine. "At NYU Langone Health, we are dedicated to advancing innovative approaches that enhance access to retinal screening while continually improving patient outcomes."

AI Optics is collaborating with NYU Langone Health to advance the accessibility of retinal screening technology. This partnership is part of the company’s broader mission to combat preventable blindness by providing innovative, practical tools for health care providers.

The Sentinel Camera features non-dilated imaging capabilities, is DICOM-compliant for seamless EHR integration, and is intentionally designed to be affordable and user-friendly. AI Optics is also developing AI-based software to complement the device, offering comprehensive solutions for detecting conditions like diabetic retinopathy, glaucoma, and macular degeneration.

"Our vision with the Sentinel Camera is to eliminate barriers to retinal screening and ensure that every patient who needs screening has access," said Luke Moretti, co-founder and CEO of AI Optics. "This FDA clearance not only validates our progress but sets the stage for AI-powered solutions that will redefine retinal disease detection."