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 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 ...
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 ...
News Medical

FDA permits marketing of first CSF nucleic acid-based test for detection of multiple pathogens

The U.S. Food and Drug Administration today allowed marketing of the first cerebrospinal fluid (CSF) nucleic acid-based test for simultaneous detection of multiple pathogens that can cause central ...
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 ...
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 ...
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 ...
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

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.
Medscape

FDA OKs Multipathogen Nucleic Acid Test for CNS Infections

The US Food and Drug Administration (FDA) today approved the first nucleic acid-based test of cerebrospinal fluid (CSF) that can simultaneously detect 14 pathogens responsible for central nervous ...
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 ...