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• June 30, 2026

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

  bioMérieux, a world leader in the field of in vitro diagnostics, today announces the submission of the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel and the BIOFIRE® FILMARRAY® Gastrointestinal 1.1 (GI1.1) Panel Mid to the U.S. Food and Drug Administration (FDA) for 510(k) review. 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 approximately one hour.

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• June 26, 2026

  Advancing Women’s Health with Rapid Diagnostics: bioMérieux files a Dual 510(k) /CLIA Waiver application to the FDA for the BIOFIRE® SPOTFIRE® Vaginitis Panel

  bioMérieux, a world leader in the field of in vitro diagnostics, has submitted a Dual 510(k)/CLIA Waiver application to the U.S. Food and Drug Administration (FDA) for the BIOFIRE® SPOTFIRE® Vaginitis (VG) Panel. This automated, multiplex PCR test can simultaneously detect the most common causes of vaginitis in 20 minutes, directly at the point of care. With this submission, bioMérieux is intending to expand into women’s and sexual health, bringing rapid and accurate diagnostics closer to patients.

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• June 18, 2026

  bioMérieux introduces Salmonella testing kit on GENE-UP® TYPER to support root cause analysis in the food industry

  bioMérieux, a world leader in the field of in vitro diagnostics, today introduces the launch of GENE-UP® TYPER SLM, a new real-time PCR solution supporting rapid root cause analysis by discriminating Salmonella in the food industry environments.

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