SyncThink, a next generation neurotechnology company, and makers of the award-winning EYE-SYNC technology, announces today that it has completed CE Mark certification, affirming conformity to European Medical Device Regulation (MDR), also known as ISO 13485. EYE-SYNC will be registered as a Class I medical device.
“The CE Mark authorization for EYE-SYNC is a tremendous advancement in our commitment to bringing objective, reliable measures of neurological function to healthcare providers in Europe,” said SyncThink CEO Gary Gregory. “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 commercialization 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, utilizing the most recent version of EYE-SYNC that comes equipped on PicoXR’s Neo 3 Pro Eye.
The CE Mark is the latest advancement among a series of growth announcements for the company. In addition to the PicoXR partnership, SyncThink recently announced the expansion of their clinical advisory board, shortly after receiving their second FDA clearance for EYE-SYNC as an Aid to Concussion Diagnosis or mild Traumatic Brain injury (mTBI). Earlier this year, SyncThink was selected by Augmented Reality (AR) leader Magic Leap as a partner in their efforts to expand into healthcare worldwide.
The EYE-SYNC technology combines proprietary software and data analytics with high performance 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 centers, sports, military, and in CNS drug development around the world.
The Conformitè Europëenne (CE) Mark confirms the manufacturer’s goods conform with European health, safety, and environmental protection standards.
It is defined as the European Union’s (EU) mandatory conformity marking for regulating the goods sold within the European Economic Area (EEA) since 1985. The CE marking represents a manufacturer’s declaration that products comply with the EU’s New Approach Directives. These directives not only apply to products within the EU but also for products that are manufactured in or designed to be sold in the EEA. This makes the CE marking recognizable worldwide even to those unfamiliar with the EEA.