Jan. 8, 2025 — Mineralys Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases, has announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) Application for a Phase 2 clinical trial to evaluate the effect of lorundrostat in the treatment of subjects with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The Company anticipates initiating the trial in the first quarter of 2025.

Jan. 7, 2025 — FIRE1 recently announced it has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and has been accepted into the FDA’s Total Product Lifecycle Advisory Program (TAP). 

FIRE1’s Norm heart failure management system offers a unique approach for patients to manage heart failure. By enabling patients to engage in physician directed self-management, Norm reduces the burden on healthcare staff, making it easier to keep patients healthier and at home.

Jan. 6, 2025 — Medtronic plc has announced it received CE (Conformité Européenne) Mark for the Harmony Transcatheter Pulmonary Valve (TPV) System, a minimally invasive alternative to open-heart surgery for congenital heart disease patients with native or surgically repaired right ventricular outflow tract (RVOT). The Harmony TPV system has already been implanted in more than 2,200 patients and now has access to help many more patients across the European Union.

Pfizer has awarded $80,000 to Rutgers Robert Wood Johnson Medical School (RWJMS) to fund an Amyloidosis Fellowship at Robert Wood Johnson University Hospital (RWJUH), an RWJBarnabas Health facility. 

Dec. 11, 2024 — Older adults whose blood pressure fluctuates over time may be more likely to have problems with thinking and memory skills, according to a study published in the Dec. 11, 2024, online issue of Neurology, the medical journal of the American Academy of Neurology.

Dec. 11, 2024 — Genetesis, Inc. has launched the CardioFlux Membership program. CardioFlux Membership is designed to be the easiest, fastest, and safest way to repeatedly measure and monitor heart health over the course of a lifetime. Participating Members schedule regular Visits to CardioFlux Imaging Institutes (CIIs) where they receive a heart scan to track changes in their myocardial fitness over time, as measured by a CardioFlux Score.

Dec. 12, 2024 — Physicians have a new treatment option for many of the sickest pediatric patients with heart failure and cardiogenic shock. Johnson & Johnson MedTech has announced that the U.S.

Dec. 13, 2024 – Sensome has announced positive results from two studies of its Clotild Smart Guidewire System demonstrating its ability to successfully identify “fresh” clot – thrombus rich in red blood cells (RBCs) – in peripheral artery disease (PAD) and differentiate it from other tissue encountered during PAD procedures. Results from the SEPARATE and E-SEPARATE studies were presented during a trial session at the Paris Vascular Insights Course in December.

Bally Ribbon Mills (BRM) offers a broad product line of medical textiles and fabrics ideal for use in cardiovascular, orthopedic and dental prosthetic applications.

Tubular prosthesis of medical textiles can become one with the repaired vessel over time and can provide less invasive options than operations like open heart surgery. BRM’s woven seamless tubular materials for stent and knitted grafts offer solutions for aortic repair and endoluminal devices. Other BRM cardiovascular textiles facilitate Trans Aortic Valve Replacement and Aseptal Defect repair.

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