Press Releases
The Latest News at BioFire
BioFire is committed to constant innovation and continual improvement. Stay up-to-date on the most recent announcements about developments and defining moments at BioFire in the links below.
BIOFIRE® Respiratory 2.1 (RP2.1) Panel with SARS-CoV-2 obtains De Novo FDA Authorization
March 18, 2021
BIOFIRE® Respiratory Panel 2.1 plus with SARS-CoV-2 is CE marked
July 15, 2020
BIOFIRE® Respiratory Panel 2.1 (RP2.1) with SARS-CoV-2 obtains FDA Emergency Use Authorization
May 4, 2020
bioMérieux receives Emergency Use Authorization for BIOFIRE® COVID-19 test
March 24, 2020
bioMérieux submits enhanced BIOFIRE®® BCID2 Panel for FDA clearance
January 13, 2020
New Reimbursement Codes for BIOFIRE® FILMARRAY® Respiratory and Gastrointestinal Panels
April 29, 2019
bioMérieux launches the BioFire® FilmArray® Pneumonia Panels with FDA clearance and CE Marking
November 13, 2018
bioMérieux submits for FDA Clearance of the BioFire® FilmArray® Pneumonia Panel
April 19, 2018
bioMérieux receives FDA Clearance for BioFire’s FilmArray® Respiratory Panel 2 (RP2)
June 1, 2017
FilmArray® Respiratory Panel EZ is CLIA waived by the FDA
October 11, 2016
FilmArray® Torch is now FDA cleared with all 4 existing FilmArray® Panels and the system gets CE marked
April 8, 2016
BioFire’s FilmArray® Meningitis/Encephalitis Panel gets CE marked
January 26, 2016
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
January 12, 2016
BioFire Diagnostics receives a de novo clearance by the FDA for the FilmArray® Meningitis/Encephalitis panel continuing its extremely favorable business momentum
October 9, 2015
BioFire Submits De Novo Application to FDA for FilmArray® Meningitis/Encephalitis Panel
April 14, 2015
BioFire Receives FDA Clearance for the FilmArray® 2.0 System
February 26, 2015
BioFire Defense Receives Emergency Use Authorization of FilmArray® Ebola Tests
October 25, 2014
BioFire’s FilmArray® Gastrointestinal Panel Receives FDA Clearance
May 5, 2014
BioFire Submits 510(k) Application to FDA for FilmArray® Gastrointestinal Panel
February 18, 2014
bioMérieux Finalizes Acquisition of the U.S. Company BioFire
January 16, 2014
BioFire Diagnostics, Inc. Announces Intent to Merge with bioMérieux
September 3, 2013
BioFire Initiates Clinical Study for the FilmArray® Gastrointestinal Panel
July 30, 2013
BioFire Receives FDA Clearance for the FilmArray® Blood Culture Identification Panel
June 25, 2013
BioFire Obtains CE IVD Mark for FilmArray® Blood Culture Identification Panel
June 6, 2013
Request a BioFire® FilmArray® Demo
Are you ready to order the BioFire® FilmArray® or want to request a free demo? Click below to take the next step towards faster results. Our team is ready to answer all of your questions.