neuroClues, a European MedTech company specialising in the diagnosis of neurodegenerative diseases, received the MDR certificate for its groundbreaking eye-tracking device.
Innovation in the EU remains achievable with proper support and the right team. In just 4 years, the company developed a complete hardware, software, and cloud system, from incorporation to EU market access. By integrating European Medical Device Regulation (MDR) requirements from initial product design, the company achieved certification within five months, showcasing its efficient and compliant innovation process. This achievement was made possible through collaboration with their notified body, whose clinical and AI expertise streamlined the review process.
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“This marks a major milestone for the millions of people affected by neurological disorders. neuroClues’ introduction to the EU market will improve diagnosis and care pathways for millions of EU patients, bringing objectivity to current clinical practice. This represents a significant value inflection point in our mission to improve neurodegenerative disease diagnosis,” said Antoine Pouppez, CEO and co-founder of neuroClues. “It demonstrates our team’s ability to deliver in a highly regulated environment with limited resources and proves that MedTech innovation remains possible in the EU.”
This achievement was made possible thanks to the support from the board (Olivier Legrain & Diane Lejeune), the investors (White Fund, Graph Ventures, InvestBW, LeanSquare & WING), the Walloon Region and the European Innovation Council (EIC) Fund.
