AI Optics Earns FDA OK for Handheld Retinal Imaging System

AI Optics Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Sentinel Camera, a handheld retinal imaging system.

The Sentinel Camera provides point-of-care retinal imaging, meaning that some patients don’t need to visit an eye specialist’s office. It was designed to support non-dilated imaging as well as be affordable and portable, according to AI Optics.

The design was also developed to meet the needs of primary care, optometry, retail health clinics, and home health settings.

The company is partnering with NYU Langone Health to advance the retinal screening tech’s accessibility and implementation. AI Optics says its mission is to tackle preventable blindness through innovative tools. The Sentinel Camera’s FDA nod marks a crucial step in this journey thanks to the possibility to integrate high-quality, portable imaging into diverse healthcare environments.

The company is also building artificial intelligence (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.

The Sentinel Camera supports DICOM-compliant image formats, permitting integration with electronic health record (EHR) systems to streamline care coordination, billing, and data sharing.

“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.”

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