OcuSciences has obtained EU CE clearance for its OcuMet Beacon diagnostic instrument, allowing the device to be commercialized across the European Economic Area, the company said. The clearance confirms that the device meets required health, safety, and environmental protection standards.
Following the regulatory approval, OcuSciences has installed OcuMet Beacon units at medical centers in Germany, England and Wales, integrating the technology into research and clinical programs, according to the company. The installations include leading research institutions, hospitals and specialized ophthalmic centers.
The company develops advanced ocular imaging technologies intended to help clinicians detect and monitor retinal disease. The OcuMet Beacon is designed to non-invasively evaluate retinal markers and assess eye health, the company claims.
OcuSciences says the move supports its goal to expand in Europe and further validate the real-world impact of its technology. The company also highlights the global burden of vision impairment, referencing World Health Organization data that over 2.2 billion people worldwide experience vision problems.
The CE clearance and regional deployments mark a strategic expansion for OcuSciences in Europe, aligning with its mission to provide ophthalmic professionals with advanced diagnostic tools.
