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 ...
Business Wire

BioFire Initiates Clinical Study for the FilmArray® Gastrointestinal Panel

SALT LAKE CITY--(BUSINESS WIRE)--BioFire Diagnostics, Inc., recently announced that it has commenced clinical and analytical studies to evaluate the company’s FilmArray Gastrointestinal (GI) Panel, ...
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 ...
KLFY News 10

Acupath Laboratories Inc. Launches the BioFire® FilmArray® Gastrointestinal Pathogen (GI) Panel

PLAINVIEW, N.Y., Sept. 7, 2023 /PRNewswire/ -- Acupath Labs a leading provider of sub-specialized anatomic and molecular pathology services, launches the BioFire ® FilmArray ® GI Panel, a FDA-cleared ...
Finanznachrichten

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

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20160111006622/en/ FilmArray® Torch instrument ...
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 ...
Becker's ASC

How can your hospital improve clinical outcomes? Choose the right test at the right time

Payers are increasingly reimbursing hospitals for becoming more efficient while maintaining quality. In a value-based payment model, patient outcomes are of the utmost importance, and hospitals ...
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 ...
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 ...