Durham, North Carolina (PRWEB) August 21, 2013
bioMérieux today announced that it has been granted U.S. FDA 510(k) de novo clearance for VITEK® MS, the first clinical mass spectrometry MALDI-TOF-based system available in the U.S. for rapid identification of disease-causing bacteria and yeast. VITEK® MS is the latest addition to the VITEK® family of products, and it is the first system to enable detection of disease causing microorganisms in minutes: this game-changing technology can significantly improve patient care. The Cleveland Clinic recently named the technique as one of the Top Ten Breakthrough Medical Technologies of 2013.
"bioMérieux has a long history of bringing the most innovative technology to the world of microbiology, so as a world leader in clinical microbiology, we are very proud to be the first to introduce mass spectrometry to U.S. clinical laboratories in 2013, as we celebrate the Company’s 50th anniversary," said Alexandre Mérieux, Directeur Général Délégué and Vice President, Microbiology Unit. "For half a century, bioMérieux has introduced pioneering diagnostic innovations to the clinical laboratory and VITEK® MS is part of our commitment to transform microbiology diagnostics with innovative solutions providing actionable information for improved medical decisions."
"The ability for laboratories to use one device to identify almost 200 different microorganisms is a significant advance in the timely identification of pathogenic microorganisms," said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health at FDA’s
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