The Latest Cardiac and Vascular News
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™ […]
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 […]
First of its Kind FDA Action Allows In-Office and At-Home Measurement for Potentially Life-Threatening Side Effect of Certain Medications MOUNTAIN VIEW, Calif., July 8, 2021 /PRNewswire/ — AliveCor, the global leader in FDA-cleared personal electrocardiogram (ECG) technology and services, today announced it received 510(k) clearance by the U.S. Food and Drug Administration (FDA) […]
