OcuSciences has received CE clearance in the EU for its eye health diagnostic tool, OcuMet Beacon.
This regulatory achievement has led to the deployment of the diagnostic instrument across various medical facilities in the UK and Europe.
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The EU CE clearance signifies聽OcuMet Beacon’s compliance with the essential requirements for safety, health and environmental protection, allowing for its commercial distribution throughout the European Economic Area.
The first wave of installations has taken place in a range of settings including hospitals, ophthalmic clinics, and research institutions in England, Wales and Germany.
These initial sites are set to incorporate the OcuMet Beacon into their ongoing clinical studies and research initiatives, which will validate the instrument’s impact in real-world applications and contribute to the progress of ocular imaging technology.
OcuSciences CEO Kurt Riegger said: 鈥淪ecuring CE clearance is a major milestone for OcuSciences and reflects our dedication to advancing the standard of care in ophthalmology.
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By GlobalData鈥淭he growing adoption of our technology by leading ophthalmic clinical centres across Europe highlights its unique value and diagnostic potential to improve disease detection and management and [is] particularly helpful in monitoring treatment.鈥�
OcuSciences focuses on the development of retinal imagers that can detect early signs of disease in the retina.
The company has demonstrated preliminary clinical utility in detecting various conditions including glaucoma, age-related macular degeneration and diabetic retinopathy.
In May 2025, the US Food and Drug Administration cleared OcuMet Beacon, indicated for ophthalmoscope scanning for infrared and autofluorescence imaging of the retina, with or without a mydriatic agent usage.
