Blog: Taking EYE-SYNC Across the Pond: The CE Mark Significance

Last week, we announced a significant milestone in the global mission of our company, one that will allow us to commercialize EYE-SYNC into the 27 countries that make up the European Union (EU). While the CE Mark is a common designation for many medical technologies looking to sell into European markets, it is an important distinction for our startup looking to influence how care is delivered in countries other than our own. In a time when healthcare is being forced to become more patient centric than ever, areas including telemedicine, wearable technologies, and digital health represent the places where patients require better care and better access to technology. The inability to properly reach and care for these individuals is something we think about every day, so advancing the opportunities for patients to access our technology is at the core of what drove us to obtain the CE Mark.

The EYE-SYNC technology has been heavily studied, evaluated, tested, and scrutinized over the years during its development. It has gone through multiple clinical trials and regulatory processes (some of which are still ongoing). While much of our focus has been towards providing our solution to the US healthcare market, something else happened along this journey. Patients became our biggest advocates. They started to find out about us on their own, as word of mouth can so often do for new technologies. They began contacting us to ask where they could find a specialist in their country who uses EYE-SYNC. They didn’t really seem to care where, all they wanted to know was how to get access. On many occasions, we reluctantly had to inform them that we were not authorized to sell our solution in the EU yet. Now, we hope to offer them something more and make up for lost time.

The CE Mark certification will also allow us to expand our reach in European countries known for pioneering therapeutic innovations in CNS trials. Providing a platform for decentralized drug trials and a quantifiable biomarker to advance drug discovery and development is also a critical component to assisting patient outcomes with advanced therapeutics. Undoubtedly, it is a more long-term play, but one that remains important to us and our partners looking to develop these novel therapies. It is our belief that by providing our solution under these circumstances, we can support better outcomes for some of the most nefarious and debilitating neurological disorders found in every corner of the world.

While we are enthused about our plans to make an impact across the pond, our work is really just beginning. When we look back on this achievement, we hope the many clinicians and patients we’ve met and helped along the way is what stands out most.