The Latest Cardiac and Vascular News
Latest Addition to the Kosmos Platform Now Enables Full-Body Imaging at Point-of-Care in a Hand-Carried Device REDMOND, Wash.–(BUSINESS WIRE)–EchoNous, the leader in portable AI-guided ultrasound tools and software, announced today that the U. S. Food and Drug Administration (FDA) has cleared Lexsa, the company’s new 128-channel linear probe, for use […]
NEWTOWN, Pa., Aug. 17, 2021 (GLOBE NEWSWIRE) — Helius Medical Technologies, Inc. (Nasdaq:HSDT) (TSX:HSM) (“Helius” or the “Company”), a neurotech company focused on neurological wellness, today announced that it has received Breakthrough Designation from the U.S. Food and Drug Administration (“FDA”) for its PoNS™ device with the proposed indication for […]
SCHAFFHAUSEN, Switzerland, Aug. 16, 2021 /PRNewswire/ — Occlutech Holding AG (“Occlutech”), one of the world´s leading providers of minimally invasive structural heart disease devices, announces the conditional U.S. Food and Drug Administration (“FDA”) approval of its Investigational Device Exemption (“IDE”) application to conduct a pivotal study, OCCLUFLEX, comparing Patent Foramen Ovale (“PFO”) closure by […]
– Amulet is the first and only minimally invasive treatment option to offer immediate closure of the left atrial appendage (LAA), so blood-thinning medication isn’t needed following implantation – The device helps to prevent blood clots from forming and leaving the LAA, reducing the risk of stroke in patients with […]
IRVINE, Calif., Aug. 16, 2021 (GLOBE NEWSWIRE) — JenaValve Technology, Inc., developer, and manufacturer of differentiated transcatheter aortic valve replacement (TAVR) systems, today announced FDA approval for the company to initiate its Investigational Device Exemption (IDE) PMA clinical trial for the Trilogy™ Heart Valve System for severe symptomatic, high-surgical risk […]
FDA Breakthrough Designation Granted to CytoSorbents’ DrugSorb-ATR for Removal of Apixaban and Rivaroxaban to Reduce the Risk of Serious Bleeding in Urgent Cardiothoracic Surgery MONMOUTH JUNCTION, N.J., Aug. 12, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its […]
Enhanced Software Automatically Identifies Regions of Interest During the Treatment of Complex Atrial Arrhythmias CARLSBAD, Calif., Aug. 11, 2021 (GLOBE NEWSWIRE) — Acutus Medical, Inc. (Nasdaq: AFIB) (“Acutus”), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced its innovative suite of software upgrades, known […]
– Ultreon™ 1.0 Software, the first-of-its-kind imaging software, merges optical coherence tomography with the power of automation using Artificial Intelligence – The new intuitive interface provides step-by-step guidance to enhance ease of use – When combined with Abbott’s Dragonfly OpStar™ imaging catheter and PressureWire X™, the platform provides physicians with […]
KIRKLAND, Wash.–(BUSINESS WIRE)–Kestra™ Medical Technologies, Inc. announced today that the company has received U.S. Food and Drug Administration (FDA) Premarket Approval for the ASSURE® Wearable Cardioverter Defibrillator (WCD) system. The ASSURE WCD system represents the next generation of monitoring and therapy to protect patients at risk of Sudden Cardiac Death (SCD). The […]
New formulation allows for uninterrupted treatment for PAH patients temporarily unable to take oral therapy TITUSVILLE, N.J., July 30, 2021 /PRNewswire/ — The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved UPTRAVI® (selexipag) injection for intravenous (IV) use for the treatment of pulmonary arterial […]
