Mauna Kea Technologies Receives 510(k) Clearance for Portfolio of Smaller Diameter Cellvizio(R) Miniprobes
World's Smallest Microscope Gets Even Smaller
(firmenpresse) - PARIS -- (Marketwire) -- 05/16/12 -- Mauna Kea Technologies (NYSE Euronext: MKEA), leader in the endomicroscopy market and developer of Cellvizio®, the world's smallest microscope, announced today that the U.S. Food and Drug Administration (FDA) has cleared a portfolio of smaller Cellvizio Miniprobes.
"This 510(k) clearance extends the Cellvizio portfolio and will offer gastroenterologists and pulmonologists additional options when choosing Cellvizio to help them make faster and more informed treatment decisions for their patients," said Sacha Loiseau, CEO and Founder of Mauna Kea Technologies. "This represents an important regulatory milestone for the company and demonstrates our ongoing success in obtaining regulatory clearances for our latest innovations."
This group of smaller Cellvizio Miniprobes will offer physicians enhanced compatibility, access and flexibility while maintaining the same ground-breaking microscopic resolution as the current Cellvizio probes. The probes are all compatible with the recently-launched Cellvizio 100 series system which offers enhanced image quality, improved user interface, faster start-up and shut-down times, and the capability to export images to the patient's medical file.
Cellvizio provides physicians with real-time microscopic images of tissue inside the body during digestive and pulmonary endoscopy procedures. During 2011 alone, 50 peer-reviewed scientific articles were published on the technology, underscoring the value of adding cellular-level imaging to endoscopy procedures. These data show that the cellular level views provided by Cellvizio in real time may help physicians make finer assessments and decisions for their patients.
Mauna Kea Technologies is a global medical device company and leader in the endomicroscopy market. The company researches, develops and markets innovative tools to visualize and detect abnormalities in the gastro-intestinal and pulmonary tracts. Its flagship product, Cellvizio®, a probe-based Confocal Laser Endomicroscopy (pCLE) system, provides physicians and researchers high-resolution cellular views of tissue inside the body. Large, international, multi-center clinical trials have demonstrated Cellvizio's ability to help physicians more accurately detect early forms of disease and make treatment decisions immediately. Designed to improve patient outcomes and reduce costs within a hospital, Cellvizio can be used with almost any endoscope. Cellvizio has 510(k) clearance from the U.S. Food and Drug Administration and the European CE-Mark for use in the GI and pulmonary tracts.
For more information on Mauna Kea Technologies, visit
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Tel : +33 1 44 71 94 94
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Datum: 16.05.2012 - 10:20 Uhr
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