Mauna Kea Technologies has received Japan’s Ministry of Health, Labor and Welfare (MHLW) approval in for its Cellvizio flagship product.
Cellvizio is a probe-based Confocal Laser Endomicroscopy (pCLE) system designed to provide physicians and researchers high-resolution cellular views of tissue inside the body.
The approval includes a Class 1 authorization for the Cellvizio technology as well as a Class 2 designation, known as NINSHO approval, covering the use of Cellvizio probes in endoscopic use.
The approval applies to all current Cellvizio indications including gastrointestinal, urologic, and respiratory.
According to the company, Cellvizio is already shared by multiples departments, including Gastroenterology and Hepatology, Interventional Pulmonology and Urology at Fujita Health University in the Chubu region.
Mauna Kea Technologies founder and CEO Sacha Loiseau said Japan represents a critically important market for Cellvizio.
"This approval is a key milestone in our goal to make optical biopsy standard of care and to expand access to Cellvizio for the millions of patients who need it in Japan and in other countries around the world," Loiseau added.
"We very much look forward to working with the clinicians and innovators in endoscopy throughout Japan who will be using Cellvizio in the years ahead,"
Cellvizio has 510(k) clearance from the US Food and Drug Administration and the European CE-Mark for use during digestive, pulmonary and urologic endoscopy procedures, including pancreatic and biliary endoscopic explorations as well as fine needle aspiration procedures.