Business Wire

BioFire Submits Special 510(k) Application to the FDA for the use of FilmArray ® Torch, the New High Throughput FilmArray ® System with FilmArray ® Respiratory Panel

MARCY L’ETOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, LLC, its molecular ...

bioMérieux Unveils its BIOFIRE® SPOTFIRE® Molecular Testing Solution for the Pharmaceutical Industry, Redefining Rapid Mycoplasma Testing

Mérieux, a world leader in the field of in vitro diagnostics, announces the launch of BIOFIRE® SPOTFIRE® for pharmaceutical industries, where this innovative molecular testing system is designed to ...
Business Wire

bioMérieux submits for FDA Clearance of the BIOFIRE ® FILMARRAY ® Pneumonia Panel

MARCY L’ÉTOILE, France--(BUSINESS WIRE)--Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology ...
Nasdaq

bioMérieux: BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 Obtains FDA Emergency Use Authorization

MARCY L’ÉTOILE, France--(BUSINESS WIRE)-- Regulatory News: bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that BioFire Diagnostics, its subsidiary ...
FierceBiotech

One-hour Ebola test from bioMérieux receives FDA emergency use authorization

The U.S. Food and Drug Administration has given a temporary thumbs up to Ebola test FilmArray BioThreat-E from BioFire Defense, a bioMérieux company. The test offers results in one hour rather than ...
PE Hub

BioFire Diagnostics Ink $25M

BioFire Diagnostics Inc. has raised $25 million in new funding from New York-based Athyrium Opportunities Fund. The money will be used to help commercialize the company’s “FilmArray” diagnostic ...
Becker's ASC

Missed opportunities for treatment: How FilmArray can boost acute gastroenteritis diagnosis

On July 28, BioFire sponsored a webinar titled “The Clinical IMPACT of the FilmArray GI Panel.” The webinar featured Kimberle Chapin, MD, DABMM, FCAP, Director of Microbiology and ID Molecular ...
elEconomista

BioFire Obtains CE IVD Mark for FilmArray® Blood CultureIdentification Panel

BioFire Diagnostics, Inc. announced today that it obtained the CE IVD Mark under the European Directive on In Vitro Diagnostic Medical Devices for its FilmArray Blood Culture Identification (BCID) ...
FierceBiotech

FDA signs off on BioFire Diagnostics' rapid meningitis test

BioMérieux's BioFire Diagnostics got an FDA OK for its rapid meningitis and encephalitis test, a feather in the company's cap as it diversifies its portfolio and ramps up business in an increasingly ...