BOSTON — Mauna Kea Technologies has secured regulatory approvals to commercialize its Cellvizio system in Switzerland and the United Kingdom, a move the company said will accelerate its international expansion and open access to two key European healthcare markets.
The approvals allow the company to begin sales in countries widely recognized for their leadership in interventional gastroenterology. The clearances follow the company’s recent CE MDR certification and align with a new commercial organization announced earlier this year aimed at driving growth outside the United States.
Alongside the regulatory milestones, Mauna Kea Technologies said it has received its first order in Switzerland from Bern University Hospital, also known as Inselspital. The hospital will install the next-generation Cellvizio Gen 3 platform, which will be used for applications related to functional intestinal barrier disorders.
The company said entry into the United Kingdom and Switzerland provides access to a dense network of specialized healthcare institutions. In the U.K., the market includes roughly 200 NHS Trusts and several hundred accredited endoscopy sites, most within the public healthcare system. Switzerland’s hospital landscape includes about 275 institutions, including five major university hospitals, with advanced digestive endoscopy concentrated in centers known for rapid adoption of new technologies.
Sacha Loiseau, chairman and chief executive officer of Mauna Kea Technologies, said the approvals represent a key step in the company’s growth strategy.
“Obtaining these approvals in Switzerland and the United Kingdom shortly after our CE MDR certification marks an important milestone in our expansion strategy beyond the United States,” Loiseau said. “These markets represent an immediate opportunity for both Cellvizio and CellTolerance. The installation of the new Cellvizio Gen 3 system at Bern University Hospital is a first concrete validation of this momentum and reflects the confidence of leading European clinicians in our technology.”
Loiseau added that the company is entering 2026 with strong commercial momentum in both the U.S. and international markets, supported by growing interest from clinicians and healthcare institutions.
