The Latest Cardiac and Vascular News
Company advances global neuro-intervention footprint with new CE-marked devices for vasospasm and stroke, and expanded U.S. indications for aspiration catheters. PLANO, Texas, Feb. 10, 2026 /PRNewswire/ — Vesalio, a global leader in vascular intervention, today announced CE Mark…
HONG KONG, Feb. 9, 2026 /PRNewswire/ — Peijia Medical Limited (HKEX: 9996) today announced that it has formally submitted the European Union Medical Device Regulation (EU MDR) CE Mark registration application for its internally developed GeminiOne Transcatheter Edge-to-Edge Repair (TEER)…
Abbott’s TactiFlex™ Duo Ablation Catheter, Sensor Enabled™, is designed with dual-energy to treat atrial fibrillation patients with the most challenging cases It can deliver both radiofrequency energy and pulsed field ablation (PFA) energy during procedures to target and treat an…
KAI 12L, the AI powering Kardia 12L, adds five new detections to further expand diagnostic capabilities for the world’s first handheld 12-lead ECG with a unique single-cable design. KAI 12L, the AI powering Kardia 12L, adds five new detections to further expand diagnostic capabilities for the world’s first handheld 12-lead ECG with a unique single-cable design.
BIRMINGHAM, Ala. — January 8, 2025 — Rampart, a Birmingham, Alabama–based medical device company redefining interventional radiation safety, today announced the launch of the SECURE Clinical Program, Studies Evaluating Clinical Utility of Radiation mitigation Equipment, a first-of-its-kind, multi-specialty clinical initiative designed to further advance the scientific evidence for next-generation radiation […]
The GORE® VIABAHN® FORTEGRA Venous Stent is engineered to offer an optimal balance of conformability and compression resistance for treating a broad range of patients. FLAGSTAFF, Ariz., Jan. 6, 2026 /PRNewswire/ — W. L. Gore & Associates’ medical business (Gore) has announced the FDA…
Sonico-CX provides a safe and effective option for treating calcified coronary lesions. SINGAPORE, Jan. 6, 2026 /PRNewswire/ — Spectrumedics Medical (hereinafter “Spectrumedics”) is pleased to announce that its Sonico-CX Intravascular Lithotripsy (IVL) System has obtained CE Mark…
SAN JOSE, Calif.–(BUSINESS WIRE)–Shape Memory Medical Inc., innovator of the proprietary shape memory polymer technology for endovascular applications, announced that its IMPEDE® Embolization Plug product family has received certification as a Class III device under the European Union (EU) Medical Device Regulation (MDR) 2017/745. The IMPEDE Embolization Plug family, previously […]
HAYWARD, Calif.–(BUSINESS WIRE)–Pulse Biosciences, Inc. (Nasdaq: PLSE), a company leveraging its novel nPulse™ technology using its proprietary Nanosecond Pulsed Field Ablation™ (nanosecond PFA or nsPFA™) energy, today announced that the U.S. Food and Drug Administration (FDA) has granted approval for the Company’s Investigational Device Exemption (IDE), allowing Pulse Biosciences to […]
Southlake, TX, Dec. 15, 2025 (GLOBE NEWSWIRE) — HeartSciences Inc. (Nasdaq: HSCS; HSCSW) (“HeartSciences” or the “Company”), a healthcare information technology (“HIT”) company advancing the use of ECG/EKGs through the integration of artificial intelligence (“AI”), today announced it has submitted its MyoVista® wavECG™ device to the U.S. Food and Drug Administration (“FDA”) for 510(k) premarket clearance.
