Media & Press relations

Our latest press releases

November 10, 2026

bioMérieux receives U.S. FDA 510(k) Clearance and IVDR CE marking for VITEK® PRO, its new automated ID/AST instrument to support the fight against antimicrobial resistance

bioMérieux, a world leader in the field of in vitro diagnostics, today announced that VITEK® PRO has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) and the CE marking under IVDR*. This innovative system for microbial identification (ID) and antimicrobial susceptibility testing (AST) supports clinical laboratories in diagnosing infectious diseases and advancing Antimicrobial Stewardship (AMS) efforts. The commercial launch of the solution is planned to begin in the first quarter of 2027.

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November 09, 2026

bioMérieux receives U.S. FDA 510(k) clearance for the latest versions of the BIOFIRE® FILMARRAY® Gastrointestinal Panels to enhance detection of gastrointestinal pathogens including norovirus

bioMérieux, a world leader in the field of in vitro diagnostics, today announces that the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel has obtained U.S Food and Drug Administration (FDA) 510(k) clearance and IVDR1 CE marking, and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid has received US FDA 510(k) clearance. These PCR* molecular panels test 22 and 11, respectively, of the most common bacteria, viruses, and parasites associated with gastroenteritis, all from one sample, with results available in about one hour.

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November 03, 2026

Third-Quarter 2026 Business Review

bioMérieux, a world leader in the field of in vitro diagnostics, today releases its business review for the nine months ending September 30, 2026: Solid performance in Q3 2026 with +8% organic sales growth.

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October 22, 2026

bioMérieux receives Dual 510(k) Clearance and CLIA Waiver from the FDA for the BIOFIRE^® SPOTFIRE^® Vaginitis Panel to Advance Women’s Health with Rapid Molecular Diagnostics

bioMérieux's BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel has received Dual 510(k) Clearance and CLIA Waiver* from the U.S. Food and Drug Administration (FDA).

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