Mauna Kea wins FDA 510(k) for Cellvizio

Mauna Kea (ENT:MKEA) said yesterday its Cellvizio confocal laser endomicroscopy platform won FDA 510(k) clearance for use during surgical procedures for treating multiple types of cancer.

The Cellvizio device is designed for use in a variety of surgical procedures, providing real time visualization at the microscopic level, Mauna Kea said

“This is a historic regulatory and business milestone for Mauna Kea Technologies that will have a strong impact on the value of our proprietary endomicroscopy technology,. This is the first clearance for this technology in surgery in the United States, making it possible for surgeries to be performed with real-time visualization of tissues at the microscopic level, enabling a new level of precision and confirmation for surgeons,” CEO Sacha Loiseau said in a press release.

Paris-based Mauna Kea said the clearance will allow operating physicians to identify cancerous tissue and guide treatments with the device during surgery.

Image guidance is provided through the Celioflex probe, delivered endoscopically or laproscopically through a trocar. Visuals are fed back in real time during surgery, allowing surgeons to see metastasis that may not be visible during preoperative imaging.

“Earlier in October we announced our marketing strategy based on development of new partnerships positioned to incorporate Cellvizio into their established platforms. This FDA clearance positions our imaging technology for use with potentially millions of new patients each year, representing a significant value proposition for our partners in the years ahead,”  Loiseau said in prepared remarks.

The company said its Cellvizio device is currently being researched in several major clinical studies.

In July, Mauna Kea won CE Mark approval in the European Union for its Cellvizio 800 near-infrared platform for endomicroscopic navigation during minimally invasive surgery.

The device is now indicated for use in gastroenterology, pulmonary and urinary treatments. The Cellvizio platform is complementary to existing platforms, such as the Intuitive Surgical‘s (NSDQ:ISRG) Firefly, the company said.

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