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. […]
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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 […]
IDbyDNA Improves Analytical Performance and User Experience of Its Explify Platform and Respiratory and Urinary Pathogen ID/AMR Panels
IDbyDNA develops Precision Metagenomic solutions with faster, comprehensive pathogen identification, quantification, and profiling powered by AI-driven genomic analysis and next-generation sequencing. […]
Biotech Perfect Day opens Location in BioHive Hub
The Gateway, a growing campus for life sciences companies, will expand and diversify the footprint of Perfect Day’s technology capabilities and teams […]
Thermo Fisher Scientific Expands in Utah with New Bioprocessing Manufacturing Site in Ogden
Company now employs more than 2,000 people state-wide across three locations […]
Merit Medical Receives FDA Clearance for SCOUT Bx™ Delivery System
New technology is designed to allow physicians to place SCOUT® reflector at time of biopsy for breast localization under stereotactic and MRI guidance […]
Merit Medical Receives FDA “Breakthrough Device Designation” for Embosphere® Microspheres for Use in Genicular Artery Embolization for Symptomatic Knee Osteoarthritis
SOUTH JORDAN, Utah, March 07, 2022 (GLOBE NEWSWIRE) — Merit Medical Systems, Inc. (NASDAQ: MMSI), announced today that it has received “breakthrough device designation” from the U.S. Food & Drug Administration (FDA) for Embosphere® Microspheres for the Genicular Artery Embolization (GAE) indication. GAE is a procedure intended to reduce pain and disability caused by knee osteoarthritis by […]
Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for Hepatitis C Viral Load Test
Co-Diagnostics announced that CoSara Diagnostics has received clearance by the CDSCO in India to manufacture and sell its SARAQ™ Hepatitis C Viral Load Kit as an in vitro diagnostic. […]
2022 Medical Design Excellence Awards Winners: Radiological, Imaging, and Electromechanical Devices
Turner Imaging’s SmartC was recently recognized as a 2022 Medical Design Excellence Award Winner by the Medical Device and Diagnostics Industry QMed. […]
Forbes Recognizes Recursion as a Best Startup Employer
Congratulations to the Recursion team and CEO Chris Gibson on making the Forbes’ list of America’s Best Startup Employers for 2022. […]
Alucent Biomedical Announces First Patient Enrolled in First in Human Natural Vascular Scaffolding Clinical Trial
Multicenter ACTIVATE II Study to Enroll up to 50 Patients in Australia […]