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Author Archives: Press Release

bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel

By Press Release | Published May 25, 2022

Marcy l’Étoile, France – bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® Joint Infection (JI) Panel has received De Novo authorization from the US Food and Drug Administration (FDA). This panel tests for 31 pathogens implicated in most acute joint infections, and also includes 8 antimicrobial resistance (AMR) […]

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PolarityTE to Effectuate 1-for-25 Reverse Stock Split

By Press Release | Published May 18, 2022

PolarityTE announced that the Company will effectuate a 1-for-25 reverse stock split of the Company’s issued and outstanding common stock.

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PolarityTE Reports First Quarter 2022 Financial Results and Provides Business Update

By Press Release | Published May 16, 2022

PolarityTE provided a business update and reported financial results for the three-month period ended March 31, 2022.

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PolarityTE Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to SkinTE®

By Press Release | Published May 16, 2022

PolarityTE announced that the U.S. FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company’s open IND. 

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IONIQ Receives Three Awards including ‘Best Medical Technology Company 2022’

By Press Release | Published May 11, 2022

IONIQ Receives Three Awards including ‘Best Medical Technology Company 2022’

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BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder (OAB) Treatment

By Press Release | Published May 11, 2022

RENOVA iStim™ implantable tibial neuromodulation device is being studied as a minimally invasive, patient-centric solution for the treatment of OAB.

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New Executive Appointments Position ARUP Laboratories for Future Growth

By Press Release | Published May 11, 2022

New Executive Appointments Position ARUP Laboratories for Future Growth

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First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial

By Press Release | Published May 11, 2022

Foldax announced that the first patients have been enrolled in the Drugs Controller General of India (DCGI)-approved clinical trial of the TRIATM biopolymer surgical aortic heart valve.

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BioMérieux Joint Infection Panel Gets FDA De Novo Authorization

By Press Release | Published May 4, 2022

BioMérieux said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo authorization from the US Food and Drug Administration. 

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PolarityTE Announces First Subject Enrolled in Phase III Pivotal Study Evaluating Investigational New Drug SkinTE® in Diabetic Foot Ulcers

By Press Release | Published May 4, 2022

SALT LAKE CITY, May 3, 2022 /PRNewswire/ — PolarityTE, Inc. (Nasdaq: PTE) today announced the enrollment of the first subject in the Phase III pivotal study evaluating SkinTE in the investigational use of treatment of Wagner grade 2 diabetic foot ulcers (DFUs), entitled “Closure Obtained with Vascularized Epithelial Regeneration for DFUs with SkinTE,” or “COVER […]

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CenExel Acquires iResearch

By Press Release | Published May 4, 2022

Premier CNS-Focused Research Facilities in Georgia Join the CenExel Centers of Excellence Clinical Research Site Network

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IDbyDNA Improves Analytical Performance and User Experience of Its Explify Platform and Respiratory and Urinary Pathogen ID/AMR Panels

By Press Release | Published April 28, 2022

IDbyDNA develops Precision Metagenomic solutions with faster, comprehensive pathogen identification, quantification, and profiling powered by AI-driven genomic analysis and next-generation sequencing.

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