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ECCMID 2023
15 April, 2023
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel
09 February, 2023
bioMérieux, a world leader in the field of in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments (CLIA) waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel. bioMérieux also announces that it will be submitting a 510(k) for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini.
MAESTRIA™, a new generation microbiology middleware developed by bioMérieux to optimize laboratory workflow and improve patient care
31 January, 2023
Marcy-l’Étoile, France – February 1st, 2023 – bioMérieux, a world leader in the field of in vitro diagnostics, launches MAESTRIA™. This new generation middleware for the microbiology laboratory aims at providing a central software tool for the workflow management of all routine activities.
CE-marking of VIDAS® KUBE™, the next generation system in the VIDAS® immunoassay portfolio
20 December, 2022
Marcy-l'Étoile, France, December 20th, 2022 — bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE-marking of VIDAS® KUBE™, the next generation automated immunoassay system for the renowned VIDAS® range. This innovation will benefit clinical labs and food industries by providing results to help speed up patient care and protect consumers.
bioMérieux announces the CE marking of VIDAS® tests for Chikungunya virus diagnosis
13 May, 2022
Marcy-l'Étoile, France – May 13th 2022 – bioMérieux, a world leader in the field of in vitro diagnostics, announces the CE marking of its automated tests to diagnose Chikungunya virus (CHIKV) infection on immunoassay instruments of the VIDAS® range.
bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel
04 May, 2022
Marcy l’Étoile, France - bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® Joint Infection (JI) Panel has received De Novo authorization from the US Food and Drug Administration (FDA). This panel tests for 31 pathogens implicated in most acute joint infections, and also includes 8 antimicrobial resistance (AMR) genes to optimize antibiotic therapy and stewardship.
bioMérieux strengthens its commitment to fight antimicrobial resistance with the acquisition of Specific Diagnostics, an innovative company focusing on fast AST solution
12 April, 2022
Marcy l’Étoile, France, April 12th 2022 – bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has entered into an agreement to acquire Specific Diagnostics, a privately held U.S. based company that has developed a rapid antimicrobial susceptibility test (AST) system that delivers phenotypic AST directly from positive blood cultures. bioMérieux has held a minority stake in Specific Diagnostics since 2019, and the two companies had signed a co-distribution agreement covering the European market in 2021.
bioMérieux receives FDA 510(k) clearance for its VITEK® MS PRIME new MALDI-TOF mass spectrometry identification system
18 March, 2022
bioMérieux, a world leader in the field of in vitro diagnostics, announces that VITEK® MS PRIME, its new MALDI-TOF1 mass spectrometry identification system, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). This next generation system for routine microbial identification in minutes is now commercially available in countries that recognize CE-marking and in the United States.
MYACUTECASE™, a free mobile application by bioMérieux to support clinicians in decision-making and monitoring of patients using emergency and critical care diagnostics
17 February, 2022
Marcy l’Étoile, France – bioMérieux, a world leader in the field of in vitro diagnostics, launches MYACUTECASETM. This mobile application, the first of a kind developed by bioMérieux, is an aid in the interpretation of VIDAS® emergency and critical care biomarker tests.
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