Mauna Kea Technologies Gets U.S. FDA 510(K) Clearance for Use of Cellvizio During Robotic-Assisted Surgery

Published: Aug 08, 2017

Mauna Kea Technologies Receives Specific U.S. FDA 510(K) Clearance for Use of Cellvizio During Robotic-Assisted Surgery

Robotic-assisted surgery is one of the fastest growing surgical categories worldwide

Key milestone in the Cellvizio product development roadmap, moving closer to data-driven surgery

PARIS--()--Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced that it has received United States Food and Drug Administration 510(k) clearance for its CelioFlex™ UHD Confocal Miniprobes™ for use with Cellvizio in robotic-assisted surgery procedures. The intended use of CelioFlex UHD Confocal Miniprobes is to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robotic-assisted procedures. This is the 13th FDA clearance covering the Cellvizio system.

Robotic-assisted surgery allows doctors to perform many types of complex procedures with greater precision, flexibility and control than is possible with conventional techniques. There are more than 4,000 da Vinci robotic surgical systems installed around the world, with approximately 750,000 robotic-assisted procedures performed on these systems in 20161. Robotic-assisted surgery has experienced significant growth in the last several years and is expected to continue growing rapidly as new robotic-assisted surgery systems enter the market.

Sacha Loiseau, Ph.D., Founder and Chief Executive Officer of Mauna Kea Technologies, added, “This new FDA clearance is an important milestone for the company on its Cellvizio product roadmap and market expansion strategy. We see the ability to instantaneously visualize and characterize tissue at the cellular level as a natural extension to robotic-assisted procedures and enabling data-driven surgery, which will in-part rely on advanced imaging and machine learning algorithms to provide reliable, real-time tissue information to surgeons. ”

About Mauna Kea Technologies

Mauna Kea Technologies is a global medical device company focused on eliminating uncertainties related to the diagnosis and treatment of cancer and other diseases thanks to real time in vivo microscopic visualization. The Company’s flagship product, Cellvizio, has received clearance to sell a wide range of applications in more than 40 countries, including the United States, Europe, Japan, China, Canada, Brazil and Mexico. For more information on Mauna Kea Technologies, visit


This press release contains forward-looking statements concerning Mauna Kea Technologies and its activities. Such forward looking statements are based on assumptions that Mauna Kea Technologies considers to be reasonable. However, there can be no assurance that the anticipated events contained in such forward-looking statements will occur. Forward- looking statements are subject to numerous risks and uncertainties including the risks set forth in the registration document of Mauna Kea Technologies registered by the French Financial Markets Authority (Autorité des marchés financiers (AMF)) on May 13, 2016 under number D.17-0574 and available on the Company's website (, and to the development of economic situation, financial markets, and the markets in which Mauna Kea Technologies operates. The forward-looking statements contained in this release are also subject to risks unknown to Mauna Kea Technologies or that Mauna Kea Technologies does not consider material at this time. The realization of all or part of these risks could lead to actual results, financial conditions, performances or achievements by Mauna Kea Technologies that differ significantly from the results, financial conditions, performances or achievements expressed in such forward-looking statements. This press release and the information it contains do not constitute an offer to sell or to subscribe for, or a solicitation of an order to purchase or subscribe for, Mauna Kea Technologies shares in any country.

1 Intuitive Surgical Q2 2017 investor presentation


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