Mauna Kea Technologies, a company based in Paris and Boston, has reached a major regulatory milestone by obtaining CE MDR certification for its Cellvizio® system and associated probes. This certification complies with the European Regulation relating to medical devices (MDR 2017/745), thus guaranteeing compliance with the most demanding international standards in terms of safety and performance.
GMED, a renowned notified body, issued this certification, highlighting the rigor of the quality processes and the clinical performance of the Cellvizio platform. This approval facilitates the long-term marketing of the device within the European Union and other regions recognizing the CE marking.
Sacha Loiseau, Doctor of Science and CEO of Mauna Kea Technologies, highlighted the importance of this certification in the face of the strict requirements of the European Medical Device Regulation (MDR). She supports the company’s expansion strategy in the areas of pancreatic cysts and food intolerances.
R. H.
date: 2026-02-11 00:05:00