Mauna Kea receives new FDA approval for confocal laser endomicroscopy system
This marks the 16th U.S. FDA approval for the company's Cellvizio p/nCLE confocal laser endomicroscopy platform.
Mauna Kea Technologies (Paris, France) has received U.S. FDA clearance for use of the Cellvizio AQ-Flex 19 Confocal Miniprobe through existing bronchoscopes, transbronchial needles, and other bronchoscopic accessories. This marks the 16th U.S. FDA approval for the company's Cellvizio p/nCLE confocal laser endomicroscopy platform.
"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," says Pr. J. T. Annema, MD, 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 againstlung cancer."
Current navigation products provide advanced minimally invasive access to peripheral nodules, but with limited ability to achieve direct visualization outside the airways. The Cellvizio AQ-Flex 19 Confocal Miniprobe can be used through the working channel of existing navigation products to provide direct through-the-needle visualization inside peripheral lesions.
The company expects its commercial strategy in the U.S. gastrointestinal (GI) market to be the primary driver of revenue growth in 2019, according to Robert L. Gershon, CEO of Mauna Kea Technologies.
For more information, please visit maunakeatech.com.