Mauna Kea’s Cellvizio AQ-Flex 19 Miniprobe FDA Cleared for Analyzing Lung Nodules

Mauna Kea Technologies, based in Paris, France, won clearance from the FDA for its Cellvizio needle-based AQ-Flex 19 confocal miniprobe for use in sampling and imaging of peripheral lung nodules.

The product allows physicians to image lung nodules directly through existing bronchoscopes and accompanying accessories. Additionally, in some markets, it can be used to analyze other internal tissues such as within the GI tract.

“Our pioneering team has demonstrated that real-time imaging and identification of benign and malignant cellular structures inside pulmonary nodules and lymph nodes with needle-based Confocal Laser Endomicroscopy is not only feasible but highly reproducible.” in a published statement said Pr. J. T. Annema, M.D., Ph.D., chairman of the Department of Respiratory Medicine, Amsterdam University Medical Centers. “The availability of nCLE inside the lungs has clear potential to have a major impact on the diagnostic accuracy for peripheral nodules, one of the most elusive challenges in the battle against lung cancer.”

Flashback: Mauna Kea AQ-Flex 19 Miniprobe for Optical GI Biopsies…Cellvizio Confocal Laser Endomicroscopy Now Cleared in EU for Robotic-Assisted Surgeries…Mauna Kea’s Cellvizio Confocal Laser Endomicroscopy Cleared in U.S. for Neurological Procedures…Mauna Kea UroFlex Optical Biopsy Probe Cleared in Europe…Scientists Probe New Technology to Detect Cancer in Barrett’s…Endo-microscopy Technique Shows Promise for Early Colon CA Diagnosis…

Via: Mauna Kea Technologies…