Sept. 22, 2025 — Nicklaus Children's Heart Institute in Miami, Florida, is now offering bedside transcatheter patent ductus arteriosus (PDA) closures for medically fragile newborns. This new offering brings advanced therapy directly to the neonatal intensive care unit, allowing procedures to be performed within the baby's own isolette or crib. This eliminates the need to transport the infant to a catheterization laboratory or even outside of their NICU room, removing any risks associated with moving fragile babies.

Sept. 23, 2025 — CeleCor Therapeutics’ multinational Phase 3 clinical trial of its investigational heart-attack drug DisaggproT (zalunfiban) has shown positive primary efficacy and primary safety outcomes. The full results from the CeleBrate study will be released Nov. 10 as part of the late-breaking sessions at the American Heart Association Scientific Sessions in New Orleans.

Sept. 22, 2025 — Heartflow, Inc. has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Next Gen Heartflow Plaque Analysis algorithm and the platform is now available. The technology features an updated algorithm, vastly expanded nomogram, and advanced 3D color-coded visualization of plaque type, volume and distribution, empowering clinicians with the insights needed to make confident care decisions with ease.

Sept. 22, 2025 — The latest findings on heart failure (HF) published by the Heart Failure Society of America (HFSA) reveal that the lifetime risk of HF has increased to 24%, while the cost of this debilitating condition in the United States continues to soar. According to the HF Stats 2025: Heart Failure Epidemiology and Outcomes Statistics, approximately 6.7 million Americans over 20 years of age have HF, and the prevalence is expected to rise to 8.7 million by 2030.

Sept. 18, 2025 — BioCardia, Inc., a developer of cellular and cell-derived therapeutics for treating cardiovascular and pulmonary diseases, has announced the primary endpoint results of the open label roll-in cohort of the CardiAMP Cell Therapy in Chronic Myocardial Ischemia Trial.

Sept. 16, 2025 — Elutia Inc., a pioneer in drug-eluting biomatrix technologies, has published clinical and preclinical data supporting the clinical utility of a biologic envelope that secures cardiac implantable electronic devices (CIEDs), promotes tissue remodeling, and addresses bacterial colonization through localized antibiotic delivery. The data are published in the current issue of Frontiers in Cardiovascular Medicine.

Sept. 16, 2025 — Conavi Medical Corp., a commercial-stage medical device company focused on designing, manufacturing and marketing imaging technologies to guide minimally invasive cardiovascular procedures, announced it has submitted its next generation Novasight Hybrid IVUS/OCT intravascular imaging system to the U.S. Food and Drug Administration for 510(k) clearance for coronary applications.

Sept. 17, 2025 — Imperative Care recently announced positive efficacy and safety results from the pivotal Symphony-PE Trial (NCT06062329) evaluating the company’s Symphony Thrombectomy System in the treatment of acute pulmonary embolism (PE).

Sept. 8, 2025 — The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Microbot Medical's Liberty System, the first FDA cleared single-use, remotely operated robotic system for peripheral endovascular procedures. The FDA clearance positions the company to commercialize Liberty in the U.S., with the goal of transforming the field to enable accessibility to advanced robotics without the traditional constraints of capital equipment and a dedicated infrastructure.

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