PARIS & BOSTON--(BUSINESS WIRE)--Regulatory News:
Mauna Kea Technologies (Paris:MKEA) (OTCQX:MKEAY) (Euronext: MKEA) inventor of Cellvizio®, the multidisciplinary probe- and needle-based confocal laser endomicroscopy (pCLE/nCLE) platform, today announced today that it has obtained 510(k) clearance (K193416) from the U.S. Food and Drug Administration (FDA) and CE marking of the next-generation Cellvizio® endomicroscopy platform, built with the company’s new proprietary system architecture. This marks the 18th U.S. FDA 510(k) clearance of the Cellvizio® pCLE/nCLE platform.
The new Cellvizio incorporates breakthrough modular design solutions to facilitate and better integrate endomicroscopy within procedure suites as well as within third-party platforms. The new platform’s hardware and software design was built from the ground up to facilitate future developments, including integration of deep learning (artificial intelligence) capabilities for assisted image interpretation. The ergonomic and significantly reduced footprint, integrates easily with laparoscopic, advanced navigation, and robotic systems. This novel platform is also capable of hosting other proprietary endomicroscopic architectures with imaging capabilities at other wavelengths supporting fluorescence-guided surgery and molecular imaging.
With a completely redesigned user interface, Cellvizio delivers smart workflows for greater efficiency and usability. The all-new touchscreen and single-handed probe connection provide for easier setup and use. Developed to bring precision imaging to more patients with 9 dedicated Confocal Miniprobes™, the new Cellvizio delivers premium imaging capabilities, offering clinicians an efficient high-performing, imaging solution for endoscopy, interventional, and surgical operating suites.
"We are proud to announce the FDA clearance and CE marking of our next generation Cellvizio in the USA and in Europe," said Robert L. Gershon, Chief Executive Officer of Mauna Kea Technologies. "The next generation Cellvizio platform will be launched commercially in the coming months and, with its modular and flexible design as well as being AI and molecular imaging ready, will host our future innovations, indications and support partnership developments."
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/approval in a wide range of applications in more than 40 countries, including the United States, Europe, Japan, and China. 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 July 12, 2019 under number R.19-0683 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.