bioMérieux Announces Multi-Year Contracts with Premier
DURHAM, N.C. (December 13, 2004) — bioMérieux, Inc., an international leader in infectious disease and coagulation diagnostics, today announced two, three-year multi-source contracts for two product lines with Premier Purchasing Partners, LP, one of the largest group purchasing organizations in the U.S
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bioMérieux Launches Intelligent Patient Therapy Management Solution
DURHAM, N.C. (December 9, 2004) — bioMérieux, Inc. today announced the launch of its STELLARA™ Clinical Intervention and Patient Monitoring software at the American Society of Health-System Pharmacists (ASHP) forum in Orlando, Florida. Commercially available in January 2005, the STELLARA systems provide knowledge-enriched, infectious disease-specific recommendations to clinicians for medication treatment management based upon individual patient profiles, lab results and parameters.
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Ergonomic Study Reveals VITEK® 2 Causes Significantly Less Upper-Extremity Strain Than Other Systems
Durham, NC, (November 4, 2004) - bioMérieux, Inc. is pleased to release the findings of a technical ergonomic analysis that shows its VITEK ® 2 automated bacterial identification and antibiotic susceptibility testing (ID/AST) system causes significantly less strain than another manufacturer's automated ID/AST system.
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bioMérieux introduces the NucliSens® miniMAG™ system
for purification of nucleic acid with magnetic silica and the Boom method
Durham, NC (October 2004) – bioMérieux, Inc. introduces the first in a new generation of nucleic acid purification systems, the NucliSens® miniMAG™. This compact new instrument takes advantage of bioMérieux’s proprietary Boom chemistry in combination with magnetic silica particles.
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bioMérieux Aligns “Pay for Performance” to its Integrated Solutions
Approach at IDSA
September 29, 2004 – bioMérieux, Inc., a global leader in in vitro diagnostics technology, today announced it will host industry thought leaders to speak about the impact of “Pay for Performance” programs and clinical-outcomes reporting at the 42nd annual meeting of the Infectious Diseases Society of America (IDSA) at the Hynes Convention Center in Boston, MA on October 1 - 2.
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FDA update for bioMérieux customers
September 2, 2004
Dear bioMérieux customer,
As a supplier to the healthcare industry, bioMérieux
Inc operates in a regulated environment. At any time we can
have inspections by the U.S. Food and Drug Administration (FDA).
Over the past several months, FDA inspected two major bioMérieux
Inc U.S. manufacturing sites, located in St. Louis, MO and Durham,
NC. This letter is intended to share the findings of these inspections
and subsequent corrective actions, and to reassure you that
manufacturing continues at normal capacity in all sites for
all products.
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In May 2004 the U.S. Food and Drug Administration (FDA) undertook two inspections of bioMérieux facilities
Durham, N.C.
Following the inspection of the Durham, N.C. site, the FDA
issued a Form 483 and has subsequently restated these observations
in a warning letter.
bioMérieux takes the observations seriously and is
committed to working with the FDA to swiftly and comprehensively
address the observations. In response to the FDA correspondence,
bioMérieux submitted recommendations for corrective
actions on May 20, 2004.
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bioMérieux and TheraDoc Enter Exclusive Agreement for STELLARA™,
a Real-time Clinical Intervention Software System
Durham, North Carolina (April 2004) — bioMérieux, Inc. is pleased to introduce STELLARA™, a comprehensive new suite of real-time, clinical-intervention software systems that bring the microbiology results (identification/susceptibility/resistance) from bioMéreiux’s leading BacT/ALERT® and VITEK® systems directly to the pharmacist and clinician — in real time — to support quicker actionable results.
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bioMeriéux, Inc. Announces VIDAS® D-Dimer Exlusion™ is Now Cleared by the FDA to Exclude Both PE and DVT
Durham, NC (July 2004) – bioMérieux, Inc. announces that its D-dimer assay, VIDAS® D-Dimer Exclusion™, is now cleared by the U.S. Food and Drug Administration (FDA) to exclude both pulmonary embolism (PE) and deep vein thrombosis (DVT) as a diagnosis in outpatients.
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