Mauna Kea Technologies Cellvizio Endomicroscopy System Received FDA Clearance
September 2 2011
Mauna Kea Technologie has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the next-generation endomicroscopy system for the GI and pulmonary tracts, called the Cellvizio 100 Series. Launched in Europe after obtaining the CE mark in April 2011, the Cellvizio 100 Series is now ready to be released in the United States.
Used mainly in gastroenterology applications, Cellvizio provides physicians with real-time microscopic images of tissue inside the body. The images facilitate the diagnosis and surveillance of patients, improving the detection of pre-cancerous lesions and helping physicians make immediate treatment decisions for their patients.