Mauna Kea Technologies Receives FDA Clearance for New Cellvizio System

Mauna Kea Technologies has received 501(k) clearance from the U.S. Food and Drug Administration (FDA) for a new Cellvizio system functioning at a near-infrared wavelength of 785 nanometers.

Optical biopsy with endomicroscopy works by using the properties of light to enable the operator to make a real-time tissue assessment inside the body. Obtaining FDA regulatory clearance of a near-infrared version of its Cellvizio endomicroscopy technology will allow Cellvizio to be utilized to perform a broader range of microscopic tissue analysis. In particular, it may facilitate the use of Cellvizio in conjunction with macroscopic imaging systems in future surgical indications, as near-infrared is a wavelength of light that widely is used by other leading commercially available imaging technologies, notably with robotic systems.

“The FDA clearance of the 785nm wavelength is a key milestone in our long-term product roadmap that is the result of years of technical and pre-clinical development,” said Sacha Loiseau, CEO/founder of Mauna Kea Technologies. “We anticipate the Cellvizio system operating at this new wavelength will open new imaging possibilities that were previously unexplored and are of particular relevance for many potential applications. We are also excited about the new clinical research avenues and commercial developments this FDA clearance will provide the medical community.”

Mauna Kea Technologies is a global medical device company that designs, develops and markets tools to visualize and detect cell abnormalities in real time during standard gastrointestinal and pulmonary endoscopy procedures. The company’s flagship product, Cellvizio, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers with high-resolution cellular imaging of internal tissues.

Large-scale, international, multi-center clinical trials have demonstrated Cellvizio’s ability to help physicians to more accurately detect early forms of diseases and make immediate treatment decisions. Designed to help physicians in their diagnoses, provide patients with better treatment and reduce hospital costs, the Cellvizio system can be used with practically all endoscopes. Cellvizio has received CE Marking for use in the gastrointestinal tract and the urinary and respiratory systems, for endoscopic exploration of the biliary and pancreatic ducts, and for fine-needle aspiration procedures. Cellvizio also obtained SFDA regulatory approval in China and MHLW approval in Japan.

The company is headquartered in Paris, France. Its U.S. office is located in Suwanee, Ga.