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.
Schweiz
bioMérieux Announces U.S. FDA Clearance for VITEK® MS
21 August, 2013
International Experts Join Forces against Superbugs at the 4th World Forum on Healthcare-Associated Infections and Antimicrobial Resistance
27 Juni, 2013
bioMérieux commits to supporting expert-defined global priorities.
bioMérieux receives CE marking for VIDAS® 3,the new generation of VIDAS®
20 Juni, 2013
bioMérieux, a world leader in the field of in vitro diagnostics, announces that VIDAS® 3, the new generation of VIDAS®, has been granted CE marking. This instrument, which further enriches the offering of the VIDAS immunoassay product range, VIDAS and mini VIDAS®, is now commercially available in Europe and the countries that recognize the CE marking.
bioMérieux Receives FDA Approval for THxIDTM-BRAF Companion Diagnostic Test
30 Mai, 2013
bioMérieux, a world leader in the field of in vitro diagnostics, today announced that its novel molecular test THxIDTM-BRAF received PMA* approval from the FDA (Food and Drug Administration) for commercialization in the United States. This unique test is intended for the qualitative and simultaneous detection of both BRAF V600E and V600K mutations in late stage metastatic melanoma tumor samples.
VIDAS® 3, the New-generation VIDAS® Presented at the JIB International Biologists Congress
07 November, 2012
bioMérieux, a world leader in the field of in vitro diagnostics, presented today VIDAS® 3, the new generation of its automated immunoassay system, during the Journées Internationales de Biologie (JIB) congress in Paris. This latest enhancement to the VIDAS® range offers major new features including, increased automation and greater traceability.