PARIS, May 25,2016 /PRNewswire/ --
FDA 510(k) clearance covers Confocal Miniprobes used with the near-infrared Cellvizio platform for urological and surgical applications
Mauna Kea Technologies (Euronext: MKEA, OTCQX: MKEAY) inventor of Cellvizio®, the multidisciplinary confocal laser endomicroscopy (CLE) platform, today announced another important regulatory milestone in the US with the 12th 510(k) clearance from United States Food and Drug Administration (FDA). This new FDA clearance covers Confocal Miniprobes indicated for use in urological and minimally invasive surgical applications with the near-infrared Cellvizio platform.
Sacha Loiseau, Ph.D., Co-Founder and CEO of Mauna Kea Technologies, declared, "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."
Image-guided surgery with intra-operative macroscopic fluorescence systems provides surgeons with enhanced anatomical guidance. The addition of microscopic fluorescence tissue pathological assessment may provide immediate, actionable information that may be used to improve diagnostic potential and further guide surgical treatments. The Cellvizio platform with near-infrared miniprobes will be compatible and complementary to existing macroscopic near-infrared endoscopic platforms proposed by a majority of surgical endoscopy manufacturers.
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 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 www.maunakeatech.com
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 24 June 2015 under number R.15-056 and available on the Company's website (www.maunakeatech.com), 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.
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SOURCE Mauna Kea Technologies