The Latest Cardiac and Vascular News
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 […]
BiovitalsHF® Approved for Expedited FDA Review Process as a First-in-Class DTx for Heart Failure that Augments Traditional Guideline-Directed Medical Therapy BOSTON, July 29, 2021 /PRNewswire/ — Biofourmis, a Boston-based global leader in virtual care and digital therapeutics, announced today its BiovitalsHF® solution is the first-ever heart failure digital therapeutic to receive a Breakthrough Device […]
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™ […]
Clinical trial to pave the way for Synchron’s StentrodeTM to become first commercially available implantable brain computer interface NEW YORK–(BUSINESS WIRE)–Synchron, a venture-backed brain data transfer company, today announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for its flagship product, the StentrodeTM motor […]
CHELMSFORD, Mass.–(BUSINESS WIRE)–ZOLL® Medical Corporation, an Asahi Kasei company that manufactures medical devices and related software solutions, today announced that it has received FDA 510(k) clearance to release the TBI Dashboard™ feature on its Propaq® M monitor and Propaq MD monitor/defibrillator. TBI Dashboard provides clinical decision support for managing patients […]
Investigational EVAS System Designed for Patients with Complex Abdominal Aortic Aneurysm IRVINE, Calif.–(BUSINESS WIRE)–Endologix LLC, a leader in the treatment of vascular disease, today announced the company’s ChEVAS™ (Chimney EndoVascular Aneurysm Sealing) System has been granted a Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). The ChEVAS […]
SAN FRANCISCO, July 14, 2021 (GLOBE NEWSWIRE) — iRhythm Technologies, Inc. (NASDAQ: IRTC), a leading digital healthcare solutions company focused on the advancement of cardiac care, today provided comment on the recently released Centers for Medicare and Medicaid Services (“CMS”) Calendar Year 2022 Medicare Physician Fee Schedule Proposed Rule (the […]
