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.

Marcy-l'Étoile, France, December 20^th, 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.

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, 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.