Regulatory

CE Mark Granted to OcuSciences’ Diagnostic Instrument

Utilizing OcuMet autofluorescence, the OcuMet Beacon is uniquely positioned to rapidly and painlessly image the eye.

By: Michael Barbella

Managing Editor

The OcuMet Beacon requires a pupil size of 2.5mm. Photo: OcuSciences Inc.

OcuSciences Inc. has earned CE Mark certification for its OcuMet Beacon, a diagnostic instrument designed to enhance eye health assessment. In conjunction with the authorization, the company has deployed OcuMet Beacons in medical centers across Europe and the United Kingdom.

“Securing CE clearance is a major milestone for OcuSciences and reflects our dedication to advancing the standard of care in ophthalmology,” OcuSciences CEO Kurt Riegger stated. “The growing adoption of our technology by ophthalmic clinical centers across Europe highlights its unique value and diagnostic potential to improve disease detection and management and particularly helpful in monitoring treatment.”

The OcuMet Beacon’s patented and innovative autofluorescence technology provides ophthalmologists and optometrists with a new way to view ocular disease using a color-coded AF image. An imaging session only requires three to five minutes for most patients; and the product itself requires a 2.5mm pupil size, ensuring a comfortable and painless patient experience. A clinician report is generated at the end of the session for review.

The initial hospital installations span prominent research institutions, hospitals, and specialized ophthalmic centers in Germany, England, and Wales. Each site will integrate the OcuMet Beacon into its clinical studies and research programs, further validating the technology’s real-world impact and driving advancements in ocular imaging.

According to the World Health Organization, more than 2.2 billion people worldwide experience vision impairment, making earlier and more detailed assessment essential for effective treatment. By deploying the OcuMet Beacon, OcuSciences aims to equip clinicians with the tools needed to detect disease earlier and improve outcomes for patients worldwide.

OcuSciences Inc., is a commercial-stage biotechnology company developing retinal imagers to identify the signatures of retinal disease for improved (and earlier) detection. Its flagship product, the OcuMet Beacon, has been developed to automatically, rapidly, and non-invasively assess retinal markers of disease in the eye. OcuSciences has shown preliminary clinical utility in a number of disease states, including diabetic retinopathy, glaucoma, and age-related macular degeneration.

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