FDA clears Mauna Kea Technologies system for lung cancer detection

Mauna Kea Technologies’ Cellvizio system

Paris-based Mauna Kea Technologies (ENT:MKEA) said that it has received  510(k) clearance from FDA for the use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories to detect lung cancer.

Cellvizio is a multidisciplinary probe-based and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform designed to aid clinicians in the diagnosis and treatment of cancer and other diseases using real-time, in vivo microscopic visualization, according to the company. This marks the 16th 510(k) clearance of the Cellvizio platform and its entry to the interventional pulmonary market.

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