Mauna Kea Technologies this week announced that it received FDA 510(k) clearance for its Cellvizio multidisciplinary probe and needle-based confocal laser endomicroscopy.
The Paris-based company’s device was granted clearance for use of the Cellvizio 100 series platform to perform fluorescence imaging of tissues that have taken up the drug Pafolacianine, manufactured by On Target Laboratories. It is designed to be used with a molecular imaging agent for real-time in vivo visualization during endoscopic, laparoscopic and needle-based procedures.
“While the suite of tools to diagnose and treat lung cancer has evolved over the past few decades, there remains a significant unmet need to improve how early and how accurately patients can be staged and treated after lung nodule detection,” interim CEO Nicolas Bouvier said in a news release. “Importantly, this clearance represents a major step forward in the collaboration between On Target Laboratories and Mauna Kea to address significant unmet needs in interventional pulmonology and lung cancer. In addition, it opens the door for a transformational shift in the application of precision medicine to interventional pulmonology and potentially other indications as well.”