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 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 ...
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 ...
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 ...
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 ...
Reuters

Biomerieux: Filmarray Torch is FDA cleared

Tesla for years had more repeat U.S. customers than any other major automotive brand but its loyalty has plunged since CEO Elon Musk endorsed President Donald Trump last summer, according to data from ...
Reuters

Biomerieux affiliate submitted FilmArray Torch to the FDA

Jan 12 (Reuters) - Biomerieux SA : * BioFire Diagnostics, LLC, has submitted the FilmArray Torch to the U.S. Food and Drug Administration (FDA) for special 510(k) clearance for use with the FilmArray ...
Yahoo Finance

BioMerieux Joins the Ebola Bandwagon: Cepheid in Trouble?

France-based BioMerieux recently joined the elite list of Ebola diagnostic device makers that include the likes of US-based Cepheid CPHD and Germany-based altona Diagnostics. BioFire Defense, a ...
pharmaphorum

bioMérieux buys BioFire Diagnostics for $400m

France-based bioMérieux has acquired the privately held US company, BioFire Diagnostics Inc for $400 million, consolidating its position as a major player in infectious disease diagnostics. BioFire ...
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 ...
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 ...