Mauna Kea Secures CE Mark for Cellvizio 800
Mauna Kea Technologies has been granted CE Mark certification for its Cellvizio 800, an endomicroscopic intra-operative imaging platform.
The clearance allows the device to be used in gastroenterology, pulmonary and urinary indications, the French devicemaker said Wednesday.
Importantly, the device is able to operate within the same setting and wavelength as macroscopic imaging surgical systems in wide use, claims Sacha Loiseau, CEO and founder.
The devicemaker says its flagship Cellvizio system has won regulatory clearance in over 40 countries. In the U.S., the Cellvizio 800 was approved last year for gastrointestinal endoscopic procedures only. — Jason Scott