Author Archives: Natalie Themm
Rep. Mike Kennedy Visits Edwards Lifesciences
Physician and U.S. Rep. Mike Kennedy (R-UT) toured the Edwards Lifesciences plant in Draper, UT, on Wednesday.
PDV MedTech and Corscience Announce Strategic Partnership to Advance MedTech Development and Manufacturing Across the US and Europe
Collaboration connects European development expertise with U.S. manufacturing to give medtech innovators a seamless path from concept to commercialization for safety-critical medical devices.
Nomi Health CEO Mark Newman Testifies Before U.S. House on Direct Contracting
Newman presents evidence that direct contracting can lower healthcare costs, improve transparency, and return savings to workers.
Co-Diagnostics Completes Clinical and Analytical Studies in Preparation for FDA 510(k) Submission of Upper Respiratory Point-of-Care Test
More than 1,400 patients enrolled across 9 clinical sites; analytical performance testing included 27 individual studies and over 10,000 PCR test cup runs.
Cytiva Completes Doubling of Utah Site’s Liquid Media Production Capacity
Project designed to support supply chain continuity for customers relying on the company for their cell culture needs.
bioMérieux Seeks FDA Clearance for Updated Gastrointestinal Testing Panels
The new molecular panels are designed to detect up to 22 pathogens in one hour with enhanced norovirus detection.
M42’s IROS launches UAE’s first genomics-driven clinical trial to prevent Alzheimer’s disease
Alzheimer’s disease is one of the world’s most pressing health challenges, affecting more than 55 million people globally; a number expected to nearly triple by 2050.
Ratio Therapeutics Enters Strategic Actinium-225 Supply Agreement with PanTera to Support Radiopharmaceutical Development Programs
Collaboration strengthens Ratio’s long-term isotope supply strategy for clinical development and future pipeline growth.
PolarityBio Announces Submission of its Biologics License Application for SkinTE® for the Treatment of Wagner Grade 1 Diabetic Foot Ulcers
SkinTE® would be the first new biologic commercially available in the U.S. for the treatment of a common chronic wound indication in nearly 30 years, if approved.
KidneyIntelX® Delivers Unprecedented Two-Year Real-World Outcomes in Diabetic Kidney Disease: No Comparable Risk Assessment Tool Exists
Landmark study of 2,470 patients across two U.S. health systems demonstrates sustained risk-stratified improvements in kidney function, increases in guideline-directed therapy uptake, and – for the first time – measurable reduction in individual patient risk trajectories over 24 months
FDA Approves Roflumilast Cream 0.3% for Plaque Psoriasis Down to Age 2
Indication expansion addresses a major pediatric gap where topical corticosteroids are commonly used off-label yet constrained by sensitive-site and long-term continuous-use limitations.
Arcutis Launches New Virtual Health Platform Supporting Access to Care for Individuals Living with Chronic Inflammatory Skin Diseases, Including Approved ZORYVE® (roflumilast) Indications
Virtual health platform offers an additional pathway to care for the more than 45 million people in the U.S. living with eczema, seborrheic dermatitis, and plaque psoriasis.
