BOSTON — Mauna Kea Technologies said it has received certification under the European Union’s Medical Device Regulation for its Cellvizio imaging platform and associated probes, marking a key regulatory milestone for the company’s European commercial strategy.
The certification confirms conformity with EU Medical Device Regulation 2017/745 and covers the full Cellvizio system and its range of probes. It was issued by GMED, a notified body responsible for evaluating medical devices against regulatory standards. The approval allows continued commercialization of Cellvizio across the European Union and other markets that recognize the CE mark.
Mauna Kea Technologies said it is the only endomicroscopy company to obtain MDR certification under the new regulatory framework. The designation reflects compliance with updated requirements for safety, performance, and clinical evidence, which are more stringent than those under the previous European medical device rules.
The company said the certification supports the long-term deployment of Cellvizio in Europe and enables the introduction of new clinical applications, as well as the future integration of artificial intelligence capabilities within the existing regulatory structure.
“The transition to MDR represents one of the most severe challenges the MedTech sector has ever faced in Europe,” said Sacha Loiseau, Ph.D., chairman and chief executive officer of Mauna Kea Technologies. “Obtaining this certification proves once again the excellence of our quality processes and the clinical superiority of Cellvizio. It is a powerful catalyst in our European commercial expansion strategy.”
Mauna Kea Technologies said its European growth efforts are focused on two clinical areas with significant potential: pancreatic cysts and food intolerances, marketed under the CellTolerance program.
