Author Archives: Natalie Themm
Co-Diagnostics, Inc. Completes Principal Design of Test for Monkeypox Virus
Co-Diagnostics announced that it has completed the principal design work of a PCR test for the monkeypox virus currently exhibiting a multi-country outbreak.
bioMérieux receives De Novo FDA Authorization for its BIOFIRE® Joint Infection (JI) Panel
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) […]
PolarityTE to Effectuate 1-for-25 Reverse Stock Split
PolarityTE announced that the Company will effectuate a 1-for-25 reverse stock split of the Company’s issued and outstanding common stock.
PolarityTE Reports First Quarter 2022 Financial Results and Provides Business Update
PolarityTE provided a business update and reported financial results for the three-month period ended March 31, 2022.
PolarityTE Announces FDA Regenerative Medicine Advanced Therapy Designation Granted to SkinTE®
PolarityTE announced that the U.S. FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to SkinTE under the Company’s open IND.
IONIQ Receives Three Awards including ‘Best Medical Technology Company 2022’
IONIQ Receives Three Awards including ‘Best Medical Technology Company 2022’
BlueWind Medical Raises $64 Million to Fund Innovative Technology for Overactive Bladder (OAB) Treatment
RENOVA iStim™ implantable tibial neuromodulation device is being studied as a minimally invasive, patient-centric solution for the treatment of OAB.
New Executive Appointments Position ARUP Laboratories for Future Growth
New Executive Appointments Position ARUP Laboratories for Future Growth
First Patients Outside of U.S. Treated with TRIA Biopolymer Surgical Aortic Heart Valve in India Clinical Trial
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.
BioMérieux Joint Infection Panel Gets FDA De Novo Authorization
BioMérieux said on Wednesday that its BioFire Joint Infection (JI) Panel has received de novo authorization from the US Food and Drug Administration.
PolarityTE Announces First Subject Enrolled in Phase III Pivotal Study Evaluating Investigational New Drug SkinTE® in Diabetic Foot Ulcers
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 […]
CenExel Acquires iResearch
Premier CNS-Focused Research Facilities in Georgia Join the CenExel Centers of Excellence Clinical Research Site Network
