AI Optics Receives FDA Clearance, Increasing Patient Access to Retinal Screening

NEW YORK, Jan. 28, 2025 /PRNewswire/ — AI Optics Inc., an AI-focused medical device company announced today that it has received FDA 510(k) clearance for its Sentinel Camera. This handheld retinal imaging system captures high-quality images of the human eye, helping to address critical gaps in retinal disease screening through a portable and accessible solution.

Over one billion people are at risk for retinal diseases, yet access to screening remains limited due to specialist shortages, cost, and convenience barriers. The Sentinel Camera helps tackle these challenges by enabling point-of-care retinal imaging, eliminating the need for some patients to visit an eye specialist’s office. It is intentionally designed to be easy to use and support non-dilated imaging, while being both affordable and portable. The design was also developed to meet the needs of general healthcare providers, including primary care, optometry, retail health clinics, and home health settings, ensuring accessibility and practicality in these environments. 

Collaborating with NYU Langone Health
AI Optics is strategically collaborating with NYU Langone Health to advance the accessibility and implementation of retinal screening technology. This partnership aligns with AI Optics’ mission to address the global challenge of preventable blindness by providing innovative tools that meet the needs of healthcare providers and patients. The FDA clearance of the Sentinel Camera marks a pivotal step in this journey, enabling the integration of high-quality, portable imaging into diverse healthcare environments.

“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.

A Foundation for Future Innovation
AI Optics is also 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.

“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 further enhance point-of-care screening workflows and diagnostic efficiency, significantly improving early detection and outcomes for patients.

The Sentinel Camera’s development was driven by the urgent need to address the global burden of preventable vision loss. By creating tools that bring screening directly to point-of-care settings, AI Optics is empowering healthcare providers to deliver early and accurate retinal disease diagnoses to patients across diverse settings, improving accessibility and outcomes for all.

Disclosures:

• NYU Langone Health holds equity in AI Optics. These interests are being disclosed and managed in accordance with NYU Langone Health policies.

For more information about the Sentinel Camera and AI Optics’ innovative solutions, visit www.aioptics.ai.

Contact for media enquiries
Luke Moretti
Co-Founder and CEO, AI Optics
Luke@aioptics.ai

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SOURCE AI Optics Inc.