The Latest Cardiac and Vascular News
Evolut™ FX TAVR System Adds Innovative Features to Enhance Ease-of-Use and Predictable Valve Deployment DUBLIN, Aug. 24, 2021 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) approval of its newest-generation, self-expanding transcatheter aortic valve replacement (TAVR) system, the Evolut™ FX TAVR system. […]
XARELTO® is the first and only therapy indicated for both coronary artery disease (CAD) and PAD, now including PAD patients post-LER XARELTO® is the only anticoagulant in 20 years to show significant benefit in patients with PAD who remain at high risk for major thrombotic events, including acute limb ischemia […]
No Form 483 observations were issued during 5-day inspection MORRISVILLE, N.C., Aug. 18, 2021 (GLOBE NEWSWIRE) — Liquidia Corporation (NASDAQ: LQDA) announced today that the U.S. Food and Drug Administration (FDA) has completed an on-site Pre-Approval Inspection (PAI) of its Morrisville, North Carolina facility in connection with the on-going review […]
BOULDER, Colo., Aug. 18, 2021 /PRNewswire/ — CardioNXT announced today that it received marketing clearance from the U.S. Food and Drug Administration (FDA) for the platform technology comprised of the iMap 3D Navigation & Mapping System™, Activate Software™, Sensor Enabled Axis Patient Patches™, and MultiLink Sensor Enabled Catheter™. The CardioNXT technology platform enables […]
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 […]
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 […]
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 […]
AI Algorithms Enhance LINQ II™ Insertable Cardiac Monitor Diagnostic Accuracy for Improved Management of Patients DUBLIN, July 28, 2021 /PRNewswire(opens new window)/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced U.S. Food and Drug Administration (FDA) clearance for two AccuRhythm™ AI algorithms for use with the LINQ II™ […]
