SyncThink announced today that it has gained CE-mark certification for its EYE-SYNC technology, affirming conformity to the European Medical Device Regulation (MDR). EYE-SYNC will be registered as a Class I medical device, according to a company press release.
“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,” 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 commercialisation of EYE-SYNC in the European Union (EU) and the UK, expanding opportunities for new business development and distribution in applicable nations, the release continues. Providers in these areas will be able to purchase and implement the EYE-SYNC system beginning this month (August 2022), utilising the most recent version of EYE-SYNC that comes equipped on PicoXR’s Neo 3 Pro Eye.
In addition to partnering with PicoXR, SyncThink recently announced the expansion of its clinical advisory board, shortly after receiving a second US Food and Drug Administration (FDA) clearance for EYE-SYNC as an aid to concussion diagnosis or mild traumatic brain injury (TBI).
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, according to the release.