AI Optics received FDA 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system that captures high-quality images of the human eye.
The Sentinel Camera enables point-of-care retinal imaging, eliminating the need for some patients to visit an eye specialist's office, the company said in a press release. It is designed to be easy to use and support non-dilated imaging—the design was developed to meet the needs of general health care providers, including primary care, optometry, retail health clinics and home health settings.
In addition, AI Optics announced it is strategically collaborating with NYU Langone Health to advance the accessibility and implementation of retinal screening technology.
"Early detection of retinal diseases is critical to preserving vision. At NYU Langone Health, we are dedicated to advancing innovative approaches that enhance access to retinal screening while continually improving patient outcomes" 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.
In addition, AI Optics also announced it is developing AI-based retinal screening software for future integration, with a plan to provide a comprehensive end-to-end solution for detecting retinal diseases like diabetic retinopathy, glaucoma and macular degeneration.
According to AI Optics, the Sentinel Camera supports DICOM-compliant image formats, allowing integration with electronic health record systems to streamline care coordination, billing and data sharing. When combined with AI Optics' upcoming AI capabilities, the system will further enhance point-of-care screening workflows and diagnostic efficiency, significantly improving early detection and outcomes for patients, the company said.
Disclosures:
NYU Langone Health holds equity in AI Optics. These interests are being disclosed and managed in accordance with NYU Langone Health policies.