Yearly Archives: 2024
bioMérieux receives U.S. FDA Special 510(k) clearance and CLIA-waiver for its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini
Marcy-l’Étoile (France), June 26th, 2024 – bioMérieux, a world leader in the field of in vitro diagnostics, today announces that its BIOFIRE® SPOTFIRE® Respiratory/Sore Throat (R/ST) Panel Mini has received U.S. Food and Drug Administration (FDA) Special 510(k) clearance and CLIA-waiver (Clinical Laboratory Improvement Amendments). The COVID-19 pandemic demonstrated the need for healthcare professionals to […]
Foldax® Reports Positive Clinical Results for TRIA Mitral Surgical Heart Valve Using Novel LifePolymer Material
SALT LAKE CITY – June 11, 2024 – Foldax®, Inc., a leader in the development of innovative, polymer heart valves, today announced positive 30-day results from a prospective, multicenter, single-arm, clinical study of the TRIA™ mitral surgical heart valve with LifePolymer™ conducted in India. At 30 days following surgery, TRIA demonstrated favorable safety and hemodynamics, […]
BioUtah Organizes Stryker, bioMérieux Tours for State Legislators
State legislators got a first hand look at Utah’s life sciences industry.
New FDA Cleared Balloon Catheter Used for Vessel Occlusion During Patient Resuscitation
Temporary vessel occlusion a growing practice for trauma patients.
SINTX TECHNOLOGIES TO EXPLORE STRATEGIC OPPORTUNITIES
SINTX Technologies announced that its Board of Directors has initiated a process to explore potential strategic options for the Company.
PhotoPharmics Enrolls First 25 Patients in Pivotal Parkinson’s Disease Study to Improve Symptoms Beyond the Current Standard of Care
Groundbreaking at-home pivotal trial of a much-anticipated therapeutic device is underway
Medicare Issues Final Coverage Determination for kidneyintelX.dkd
Company has Achieved Prerequisites for Growing Test Adoption with FDA Authorization, Clinical Outcomes Data, Inclusion in Clinical Guidelines, and Broad Insurance Coverage
Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro Platform
The Company expects that the application for OTC clearance will shortly be followed by pursuit of POC clearance, with other tests in the pipeline to meet the needs of a global market
Canary Speech Secures $13 Million in Series A Funding
Led by Cortes Capital, LLC, Sorenson Communications, LLC., SMK (Japan), and Hackensack Meridian Health, Series A funding expands the AI-driven capabilities of the groundbreaking vocal biomarker health tech company PROVO, Utah, June 12, 2024 /PRNewswire/ — Canary Speech, Inc. (Canary), the leading AI-powered voice biomarker health tech company, has secured a $13 million Series A […]
ARUP Celebrates 40th Anniversary With Focus on the Future of Laboratory Medicine
ARUP Laboratories’ commitment to advance laboratory medicine was on full display on June 13 as the company hosted an Innovation Showcase as part of its 40th anniversary celebration. ARUP has grown from a small startup established in 1984 with about 100 employees into one of the nation’s four largest reference laboratories and one of Utah’s […]
Myriad Genetics Collaborates with GSK to Improve Access to HRD Testing in 9 Countries
New sponsored testing program leverages Myriad’s MyChoice Tests for patients with high-grade serous ovarian cancer
Owlet Expands Global Footprint with Launch of Medically-Certified Dream Sock™ in the UK and Across Europe
Owlet Expands Global Footprint with Launch of Medically-Certified Dream Sock™ in the UK and Across Europe
