technologynetworks

Idaho Technology Launches FilmArray(R) Respiratory Panel

Idaho Technology, Inc. announced the European launch of its FilmArray Respiratory Panel (FilmArray RP), a multiplex clinical diagnostic product that simultaneously detects 21 respiratory pathogens in ...
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 ...
Firehouse

FDA Clears Idaho Technology's FilmArray Instrument

SALT LAKE CITY, UT - Idaho Technology, Inc. (ITI) announced today that the U.S. Food and Drug Administration has issued a 510(k) clearance for the FilmArray instrument and the FilmArray Respiratory ...
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 ...
Medscape

FDA Approves Addition of 3 Bacteria to Respiratory Panel

May 18, 2012 — The US Food and Drug Administration (FDA) has given 510(k) clearance to the FilmArray Respiratory Panel to include testing for Bordetella pertussis, Mycoplasma pneumoniae, and ...
Pharmabiz

Idaho Technology gets US FDA clearance for expanded FilmArray RP

Idaho Technology, Inc.,(ITI) a privately held clinical diagnostics company, has received the US Food and Drug Administration (FDA) 510(k) clearance of five additional pathogens for its FilmArray ...
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 ...
Reuters

Biomerieux' Filmarray Respiratory Panel EZ is CLIA waived by the FDA

* Filmarray RP EZ will be available on the US market only, Biofire anticipates commercial launch in November 2016 Source text for Eikon: Further company coverage: ...
Labroots

Combining Procalcitonin and a Highly Multiplexed Syndromic...

This webinar will discuss how combining VIDAS® B•R•A•H•M•S PCT (TM) (procalcitonin) and a BIOFIRE® FILMARRAY® Respiratory Panel can optimize antimicrobial stewardship in patients with Lower ...
usace.army.mil

USAMMDA Announces FDA 510 (k) Clearance of Rapid Diagnostic Test for COVID-19

The U.S. Army Medical Materiel Development Activity’s Warfighter Protection and Acute Care Project Management Office, along with its commercial partner BioFire Defense, announced the U.S. Food and ...