The Latest Cardiac and Vascular News
CHICAGO–(BUSINESS WIRE)–GE Healthcare today announced U.S. FDA 510k clearance for its Ultra Edition package on Vivid1 cardiovascular ultrasound systems, which includes new features based on artificial intelligence (AI) that enable clinicians to acquire faster, more repeatable exams consistently. Methodical assessments of heart function are key in echocardiography but can be tedious […]
The CARTO® 3 System and THERMOCOOL SMARTTOUCH® SF Catheter allow for a patient-tailored ablation approach, resulting in high long-term effectiveness in persistent atrial fibrillation patients* IRVINE, Calif., Oct. 6, 2020 /PRNewswire/ — Johnson & Johnson Medical Devices Companies** today announced the United States Food and Drug Administration (FDA) approval of Biosense Webster, Inc.’s THERMOCOOL […]
Now Cleared for up to 48-Hour Dwell WAYNE, Pa., Oct. 01, 2020 (GLOBE NEWSWIRE) — Teleflex Incorporated (NYSE: TFX), a leading global provider of medical devices for critical care and surgery, has announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Indications […]
ST. LOUIS, Sept. 30, 2020 /PRNewswire/ — SentiAR, a pioneer in visualization technologies for surgical applications announces U.S. Food and Drug Administration (FDA) 510(k) clearance of its groundbreaking CommandEP™ system, the first holographic guidance system to be used during an invasive cardiac procedure. The CommandEP system allows electrophysiologists to visualize 3D electroanatomic models in […]
DUBLIN, Sept. 22, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), the global leader in medical technology, has received Breakthrough Device Designation status from the U.S. Food and Drug Administration (FDA) for the TYRX™ Absorbable Antibacterial Driveline Wrap, which is intended to securely hold a percutaneous driveline in patients receiving a ventricular assist device (VAD). […]
Next-generation technology provides easy, effective clot removal from peripheral arterial vasculature EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, announced it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Pounce™ Thrombus Retrieval System. […]
Design Features Improve Handling and Deliverability to Enhance Efficiency CARLSBAD, Calif., Sept. 17, 2020 (GLOBE NEWSWIRE) — Acutus Medical (Nasdaq: AFIB) today announces FDA 510(k) clearance of the second-generation AcQMap® 3D imaging and mapping catheter which builds on its predecessor, improving handling and deliverability. This flagship 3D mapping and navigation catheter combines […]
– FDA Fast Track designation facilitates the development of potential new therapies that treat serious conditions and fulfill an unmet medical need – This Fast Track designation for empagliflozin emphasizes the urgent need for potential treatments that may improve outcomes following an acute myocardial infarction, more commonly known as a […]
With FDA 510(k) clearance and CE mark, the Fitbit ECG App may help prevent serious complications like stroke by allowing users to spot check for signs of AFib from their wrist SAN FRANCISCO–(BUSINESS WIRE)–Fitbit (NYSE:FIT) has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), as well as Conformité Européenne (CE) marking […]
Medtronic Receives Breakthrough Device Designation from FDA, Begins Early Feasibility Study for Investigational Intrepid™ Transcatheter Valve System for the Treatment of Tricuspid Valve Regurgitation DUBLIN, Sept. 9, 2020 /PRNewswire/ — Medtronic plc (NYSE:MDT), a global leader in structural heart therapies, today announced U.S. Food and Drug Administration (FDA) approval of an early feasibility […]
