Oct. 27, 2025 — Elixir Medical, a developer of technologies to treat cardiovascular disease, has announced new clinical results for its DynamX bioadaptor, a coronary implant designed to restore a blood vessel’s natural movement and function, also known as hemodynamic modulation, demonstrating a 48% risk reduction in device-related cardiac events compared to current-generation drug-eluting stent.

Oct. 23, 2025— Emboline, Inc., a provider of full-body embolic protection devices for transcatheter procedures, thas completed patient enrollment in its Protect the Head to Head (ProtectH2H) Clinical Trial, a pivotal Investigational Device Exemption (IDE) trial (NCT05684146) evaluating the safety and effectiveness of the Emboliner Embolic Protection Catheter for patients undergoing Transcatheter Aortic Valve Replacement/Implant (TAVR/TAVI). Enrollment began in May 2023.

Oct. 26, 2025 – Jupiter Endovascular, Inc., a medical technology company developing a new class of endovascular interventions using its Transforming Fixation (TFX) technology, announced positive results from the SPIRARE I first-in-human (FIH) study. Data was presented at the Transcatheter Cardiovascular Therapeutics (TCT 2025) conference by Professor Irene Lang, MD, Principal Investigator and Professor of Vascular Biology at the Medical University of Vienna in Austria.

Oct. 24, 2025 —YorLabs, Inc., a medical technology company developing next-generation intracardiac imaging solutions for electrophysiology (EP) and interventional cardiology (IC) procedures, recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's YorLabs Intracardiac Imaging System — a zero-capex ultrasound platform designed to simplify workflow, reduce cost, and enhance procedural efficiency inside the cath lab.

Oct. 27, 2025 — The American Heart Association (Association) has launched its latest professional certification program to help bridge the gap between traditional practice and remote patient monitoring and care, while promoting privacy and compatibility with existing health care systems.

Oct. 27, 2025 – Penumbra, Inc. has announced the results of the STORM-PE randomized controlled trial (RCT), which found that the use of mechanical thrombectomy, specifically computer assisted vacuum thrombectomy (CAVT), with anticoagulation achieved superior reduction in right heart strain compared to anticoagulation therapy alone in patients with acute intermediate-high risk pulmonary embolism (PE). The data was presented at a late-breaking session during the 37th Annual Transcatheter Cardiovascular Therapeutics (TCT) Conference in San Francisco.

Oct. 21, 2025 — SpectraWAVE, Inc., a medical imaging company focused on improving the treatment and outcomes for patients with coronary artery disease (CAD), recently announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its wire-free, drug-free, single angiogram derived physiology product, X1-FFR. X1-FFR provides physicians physiology results from a single angiogram acquired via a direct real-time angiography feed, eliminating the need for network-based DICOM file management and transfer delays.

Oct. 22, 2025 — Heartflow, Inc. has introduced Heartflow PCI Navigator, the newest addition to the Heartflow One platform. PCI Navigator is an integrated, AI-driven percutaneous coronary interventions (PCI) planning tool that gives interventional cardiologists a patient-specific 3D model — detailing anatomy, plaque composition, and lesion-specific physiology — all aligned to optimize potential stent placement. For the first time, interventional cardiologists can plan PCIs with relevant information brought together in one intuitive view before their patients are in the cath lab.

Oct. 22, 2025 — Qure has announced its latest (510) K clearance from the US Food and Drug Administration (FDA). 

Oct. 22, 2025 — Nyra Medical, a leading innovator in structural heart therapies, has announced the initiation of its first-in-human clinical study evaluating its novel Cardiac Leaflet Enhancer (CARLEN) System in patients with functional (secondary) mitral regurgitation (FMR).

The study, focused on clinical safety and technical performance, has successfully enrolled more than 10 patients, many with at least 30-day follow-up to date. The early clinical experience marks a significant milestone in the company's mission to transform the treatment of mitral valve disease.

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