SyncThink, a neurotechnology company, and makers of the EYE-SYNC technology, has completed CE Mark certification, affirming conformity to European Medical Device Regulation (MDR). EYE-SYNC will be registered as a Class I medical device.
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CE standard mark. Icon for products sold within the European Economic Area - EEA. Europe Union color, flag, stars sign. Vector CE European Conformity - logo. Blue background
SyncThink CEO Gary Gregory said: “The CE mark authorisation for EYE-SYNC is a tremendous advancement in our commitment to bringing objective, reliable measures of neurological function to healthcare providers in Europe. We are excited to expand our commercial opportunities and strengthen our position in the market, while making our product more accessible to patients everywhere.”
The new certification allows for commercialisation of EYE-SYNC in the European Union (EU) and the United Kingdom (UK), expanding opportunities for new business development and distribution in applicable nations. Providers in these areas will be able to purchase and implement the EYE-SYNC system beginning this month, utilising the most recent version of EYE-SYNC that comes equipped on PicoXR’s Neo 3 Pro Eye.
The EYE-SYNC technology combines software and data analytics with eye tracking sensors to measure and quantify eye movement biomarkers reflective of neurological impairment or disease. It is currently used by healthcare providers in hospitals and rehabilitation centres, sports, military, and in CNS drug development around the world.
