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 ...
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 ...
Business Wire

BioFire Obtains CE IVD Mark for FilmArray® Blood Culture Identification Panel

SALT LAKE CITY--(BUSINESS WIRE)--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 ...
FierceBiotech

BioFire Diagnostics wins FDA clearance for innovative GI panel

BioFire Diagnostics won 510(k) clearance for its gastrointestinal panel for infectious diarrhea, following in the footsteps of the company's acquisition by French diagnostic giant bioMérieux.
FierceBiotech

BioMérieux's BioFire sets course for GI panel FDA clearance

Just a month out from being bought by French giant bioMérieux, BioFire Diagnostics took its FilmArray diagnostic system's new gastrointestinal option to the FDA for clearance, which the newly united ...
Finanznachrichten

BIOFIRE Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, today announced that the BIOFIRE Respiratory Panel 2.1 plus (RP2.1plus) is CE marked. The BIOFIRE Respiratory Panel 2.1 ...
Nasdaq

bioMérieux submits enhanced BIOFIRE® BCID2 Panel for FDA clearance

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 ...
technologynetworks

BioFire Dx Initiates Clinical Study for the FilmArray™ Meningitis/Encephalitis Panel

Infection of the meninges surrounding the brain and spinal cord (meningitis), or of the brain (encephalitis) can have high mortality and morbidity rates depending on the source of infection. Acute ...
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 ...
JSTOR Daily

Clinical Impact of a Multiplex Gastrointestinal Polymerase Chain Reaction Panel in Patients With Acute Gastroenteritis

Background. Molecular syndromic diagnostic panels can enhance pathogen identification in the approximately 2–4 billion episodes of acute gastroenteritis that occur annually worldwide. However, the ...
Finanznachrichten

bioMérieux submits for FDA Clearance of the BIOFIRE FILMARRAY Pneumonia Panel

bioMérieux (Paris:BIM), a world leader in the field of in vitro diagnostics, announces that BioFire Diagnostics, its molecular biology affiliate, has submitted to the Food and Drug Administration for ...