Claim: Mauna Kea Technologies, a global medical device company focused on endomicroscopy, was founded in 2000, and its Cellvizio pCLE system received U.S. Food and Drug Administration (a federal agency of the Department of Health and Human Services) clearance and CE mark in the European Union in 2005.
Evidence: Mauna Kea Technologies is a global medical device company focused on endomicroscopy, the field of microscopic imaging during endoscopy procedures. 2000 The company makes Cellvizio, a probe-based Confocal Laser Endomicroscopy (pCLE) system, which provides physicians and researchers with real-time access to histological information during standard endoscopy procedures through high-resolution cellular imaging of internal tissues. 2005 Cellvizio pCLE system receives U.S. Food and Drug Administration (FDA) clearance and CE mark in the European Union