SyncThink Secures CE Mark for EYE-SYNC Digital Health Platform

FacebookFacebookTwitterTwitterEmailEmailLinkedInLinkedInWhatsAppWhatsAppMessengerMessengerFlipboardFlipboardGmailGmailTelegramTelegramShareShare

Neurotechnology solution gains vital certification needed for EU expansion

Palo Alto, CA – (August 10, 2022) – 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) Markconfirms 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.

For more information, please visit: https://syncthink.com/

About SyncThink: SyncThink is on a mission to provide objective neurological measurements that assist medical professionals in assessing brain health, delivering therapies, and optimizing performance. SyncThink develops revolutionary eye-tracking software and analytic technologies, delivered in a rapid, accurate, and easy to use XR platform. With more than 30 published peer-reviewed papers and 15 granted patents, the SyncThink platform uses a series of 60-second assessments to objectively measure eye movements to identify impairments and offers multiple modalities to improve dynamic vision. FDA-cleared for detecting eye-tracking impairments and as an aid to concussion diagnosis, EYE-SYNC is used by leading medical centers such as Stanford and Massachusetts General, the U.S. military, and more than 20 top universities, SyncThink is transforming neurological assessment, recovery, and performance for health and sport.

user

Recent Posts

Artificial Intelligence (A.I.) in Life Science: New Survey of 408 Researchers Reveals Split Sentiment, Surging Adoption, and Rising Trust Barriers

ARLINGTON, Va., June 20, 2025 /PRNewswire/ -- New survey data from 408 global scientists and researchers…

4 hours ago

Salem Dentist (Smiles Of Salem) Stands with Veterans in National Push for Better Healthcare Protections

This Fourth of July, Dr. Harbpinder Shevchenko, DMD of Smiles of Salem is going beyond…

4 hours ago

American Textile Company’s Centennial Gala Marks 100 Years of Success!

Pittsburgh Event Celebrates Employees, Partners and a Commitment to Growth DUQUESNE, Pa., June 20, 2025…

4 hours ago

Nihar Gala Launches CareIQ, a Pioneering Remote Patient Monitoring Company, and Releases Inspiring New Book “The Strength to Endure”

SEAFORD, Del., June 20, 2025 /PRNewswire/ -- Acclaimed physician, entrepreneur, and visionary healthcare leader Nihar Gala…

4 hours ago

LevelJump Announces 2024 Financial Results

Toronto, Ontario--(Newsfile Corp. - June 20, 2025) - LevelJump Healthcare Corp. (TSXV: JUMP) ("LevelJump" or the…

5 hours ago