Mauna Kea Technologies Secures CE MDR Certification for Cellvizio®

Mauna Kea Technologies, based in Paris and Boston, has achieved a significant regulatory milestone by obtaining the CE MDR certification for its Cellvizio® system and associated probes. This certification aligns with the European Medical Device Regulation (MDR 2017/745), ensuring compliance with the highest international safety and performance standards.

GMED, a renowned notified body, granted this certification, highlighting the robust quality processes and clinical capabilities of the Cellvizio platform. This approval facilitates the long-term commercialization of the device within the European Union and other regions recognizing the CE mark.

Sacha Loiseau, Ph.D., CEO of Mauna Kea Technologies, emphasized the importance of this certification in the face of stringent European MDR challenges. It supports the company's expansion strategy in addressing pancreatic cysts and food intolerance areas.