Press Releases
Search
-
09 May 2023
bioMérieux receives US FDA CLIA-waiver for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
bioMérieux, a world leader in the field of in vitro diagnostics, has received U.S. Food and Drug Administration (FDA) Clinical Laboratory Improvement Amendments (CLIA) waiver for the fast and accurate multiplex PCR*-based BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. This waiver comes in addition to the 510(k) clearance obtained last April.
-
27 Apr 2023
bioMérieux – First-Quarter 2023 Business Review
bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the three months ended March 31th, 2023. Consolidated sales totaled €906 million in the first quarter of 2023, up 8.2% from €837 million in the year‑earlier period.
-
14 Apr 2023
Oxford Nanopore and bioMérieux to enter into a strategic partnership agreement
Oxford Nanopore Technologies plc and bioMérieux SA, a world leader in the field of in vitro diagnostics, today announced that they have teamed up to improve health outcomes globally by exploring selected opportunities to bring nanopore sequencing to the infectious disease diagnostics market.
-
13 Apr 2023
bioMérieux receives US FDA 510(k) clearance for the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini
bioMérieux has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the fast and accurate multiplex PCR*-based BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini. bioMérieux will immediately apply for Clinical Laboratory Improvement Amendments (CLIA) waiver for the test.
-
07 Apr 2023
SPECIFIC REVEAL™ Rapid AST System, newly renamed VITEK® REVEAL™, submitted to US FDA for 510(k) clearance
bioMérieux, a world leader in the field of in vitro diagnostics, announces that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the VITEK® REVEAL™, formerly known as SPECIFIC REVEAL™ Rapid AST System.
-
05 Apr 2023
bioMérieux launches BIOFIRE® FIREWORKS™, a cutting-edge, data-driven software solution
bioMérieux launches BIOFIRE® FIREWORKS™, an innovative and integrated software solution for BIOFIRE® Systems optimizing laboratory services and supporting data-driven decisions. This software is the newest addition to the BIOMÉRIEUX VISION SUITE – the company’s portfolio of Data and IT Solutions supporting increased efficiency and productivity in laboratories worldwide.
-
10 Mar 2023
BioFire Defense partners with BARDA to accelerate development of the SPECIFIC REVEAL™ Rapid AST System
BioFire Defense, LLC, has received a contract from the BARDA (Biomedical Advanced Research and Development Authority) to accelerate development of the Specific Diagnostics SPECIFIC REVEAL™ Rapid AST System that can deliver phenotypic results in an average of five and a half hours from positive blood cultures.
-
08 Mar 2023
bioMérieux 2022 Financial Results
bioMérieux announced a strong performance in 2022 with robust full-year sales at €3,589 million with a reported growth of +6.3% and an almost neutral organic growth of +0.2%.
-
08 Feb 2023
US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System
bioMérieux receives US FDA 510(k) Clearance and CLIA-waiver for the fast and innovative BIOFIRE® SPOTFIRE® System and its BIOFIRE® SPOTFIRE® Respiratory (R) Panel and will be submitting the BIOFIRE® SPOTFIRE® Respiratory (R) Panel Mini for 510(k) clearance.
-
01 Feb 2023
MAESTRIA™, a new generation microbiology middleware developed by bioMérieux
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.
-
20 Dec 2022
CE-marking of VIDAS® KUBE™, the next generation system in the VIDAS® immunoassay portfolio
VIDAS® KUBE™ is the next generation automated immunoassay system for the renowned VIDAS® range. It will benefit clinical labs and food industries by providing results to help speed up patient care and protect consumers.
-
15 Dec 2022
2022 increased outlook and 2023 preview guidance
bioMérieux, a world leader in the field of in vitro diagnostics, today released its adjusted outlook for full-year 2022 and a preview of 2023 guidance.
-
16 Nov 2022
Survey bioMérieux OpinionWay - Antimicrobial Resistance and diagnostic tests
To mark World Antimicrobial Awareness Week organized by the WHO from November 18-24, bioMérieux presents the results of a bioMérieux/OpinionWay survey on the general public's knowledge of antimicrobial resistance and the use of diagnostic tests in France.
-
26 Oct 2022
Third-quarter 2022 Business Review
bioMérieux, a world leader in the field of in vitro diagnostics, releases its business review for the nine months ended September 30, 2022.
-
26 Sep 2022
New survey shows low adherence to guidelines in sepsis care puts patients at risk
To mark Sepsis Awareness Month, bioMérieux, a world leader in in vitro diagnostics with a long-standing commitment to the fight against sepsis, and the UK Sepsis Trust, an internationally renowned charity, have released new survey data of health professionals to assess their knowledge and practice in the management of sepsis. This survey was commissioned among 368 doctors across six European countries.