Mauna Kea (ENT:MKEA) said today it won 510(k) clearance from the FDA for its Confocal miniprobes designed for use with the company’s Cellvizio platform.
The newly-cleared Confocal miniprobes are indicated for use in urological and minimally invasive surgical applications along with the near-infared Cellvizio platform, Mauna Kea said. The company touted the regulatory win as its 12th in the U.S.
“This FDA clearance is another step forward in expanding the utility of the Cellvizio platform in minimally invasive surgery and urological applications. Our near-infrared imaging products are designed to provide a positive impact on procedural outcomes by adding to fluorescence-guided procedures the precision and reliability of real-time cellular characterization. In addition to be complementary to existing intra-operative fluorescence systems that use the same near-infrared wavelength, surgical CLE data may bring physicians microscopic guidance in a wide range of surgical procedures,” Mauna Kea CEO Sacha Loiseau said in a press release.
The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said
Last month, Mauna Kea said it inked a research collaboration deal with Edinburgh Molecular Imaging to explore the combination of EM Imaging’s in vivo optical imaging agents with Mauna Kea’s confocal laser endomicroscopy platform to diagnose cancer.
EM Imaging said it will supply optical imaging agent EMI-137 to 2 investigational sites to perform clinical efficacy studies in pacnreatic and lung cancers using celular level endomiscroscopy with Mauna Kea’s Cellvizio.
The deal calls for Japan’s Fujifilm to commercialize Cellvzio for gastroenterological and pulmonary applications in the People’s Republic, and integrate the device into its own endoscopes.