Mauna Key Technologies’ Cellvizio Gains Expanded CE Mark

Mauna Kea Technologies’ Cellvizio, a confocal laser endomicroscopy platform, has received an expanded CE Mark indication for laparoscopic procedures, the French devicemaker announced.

The platform previously was indicated for use in the gastrointestinal tract and the urinary and respiratory systems, as well as the biliary and pancreatic ducts and for fine-needle aspiration procedures.

Cellvizio’s imaging system, which allows internal tissue to be visualized at the microscopic level, could enable improved frozen section sampling, more accurate tumor margin detection and better surgical planning, the company says.

Cellvizio received FDA 510(k) clearance last year. It also has been approved in China and Japan. — Jason Scott