NEW YORK—AI Optics Inc., an AI-focused medical device company, announced that it has received Food and Drug Administration (FDA) 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system that captures images of the human eye. According to the company, the Sentinel Camera helps enable point-of-care retinal imaging and is designed to be easy to use and supportive of non-dilated imaging. The design was also developed to meet the needs of general health care providers, including primary care, optometry, retail health clinics and home health settings, the company said.

AI Optics also announced a partnership with NYU Langone Health to advance the accessibility and implementation of retinal screening technology to address preventable blindness. NYU Langone Health holds equity in AI Optics, the announcement said.

“Early detection of retinal diseases is critical to preserving vision," said Kathryn Colby, MD, PhD, the Elisabeth J. Cohen, MD, professor of ophthalmology and chair of the department of ophthalmology at the 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 also developing AI-based retinal screening software for future integration, with a plan to provide an end-to-end solution for detecting retinal diseases such as diabetic retinopathy, glaucoma and macular degeneration, the company said.

“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 significant progress to breaking down screening barriers, but also sets the stage for our future AI-powered screening solutions, which will integrate seamlessly with the Sentinel Camera to deliver unparalleled accessibility and efficiency in retinal disease detection.”

The Sentinel Camera supports DICOM-compliant image formats, allowing integration with electronic health record (EHR) systems to streamline care coordination, billing and data sharing. When combined with AI Optics’ upcoming AI capabilities, the system will help further enhance point-of-care screening workflows and diagnostic efficiency, the company reported.