FDA Grants Clearance for OcuMet Beacon Retinal Imaging Device
OcuSciences, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted regulatory clearance for its flagship diagnostic device, the OcuMet Beacon. According to the company’s press release, the device will soon become available for clinical use across healthcare institutions in the United States.
Overview of OcuMet Beacon’s Retinal Imaging Capabilities
The OcuMet Beacon is designed to assess retinal health by detecting naturally occurring autofluorescence (AF) and infrared (IR) signals from the human retina. Utilizing proprietary illumination and detection technology, the system enables noninvasive retinal imaging without the need for injections, dyes, or direct physical contact with the eye.
The device is FDA-cleared for ophthalmoscope scanning of the retina with or without the use of a mydriatic agent, supporting both IR and AF imaging modes.
Kurt Riegger, CEO of OcuSciences, emphasized the potential of the device:
“With our collaborators, we are extending the depth of understanding for retinal diseases. This is a game-changer for the many patients and ophthalmologists who stand to benefit from more precise and deeper insight.”
Clinical Validation and Upcoming Research Presentations
The safety and clinical utility of the OcuMet Beacon have been demonstrated in a broad body of peer-reviewed clinical studies. In addition, the company confirmed that 12 new clinical studies showcasing expanded applications of the device will be presented at the upcoming Association for Research in Vision and Ophthalmology (ARVO) 2025 Annual Meeting.
These developments position OcuMet Beacon as a novel diagnostic solution poised to enhance retinal disease evaluation and management across clinical settings.
