The Latest Cardiac and Vascular News
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 […]
Designation Expedites Physician Access to Device for Patients with Extremely Long and Complex SFA Lesions MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass Inc, a medical device pioneer bringing new advancements to the treatment of advanced peripheral artery disease (PAD), announced today that they received Breakthrough Device designation from the U.S. Food and Drug […]
Revised Commercial Labeling Broadens Patient Population Who May be Candidates for Transcatheter Aortic Valve Replacement (TAVR) DUBLIN, Aug. 21, 2020 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT), the global leader in medical technology, today announced the U.S. Food and Drug Administration (FDA) has approved revised commercial labeling for the Evolut™ TAVR platform […]
EDEN PRAIRIE, Minn., Aug. 18, 2020 (GLOBE NEWSWIRE) — CHF Solutions (Nasdaq: CHFS), a medical device company dedicated to improving the lives of patients suffering from fluid overload, today announced that its Aquadex™ product line has been added to the Federal Supply Schedule, expanding access to all federal government agencies, […]
HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease received approval from FDA of an investigational device exemption, or IDE, to start the TRIOMPHE study on the NEXUS™ Aortic Arch Stent Graft System (hereinafter referred to as NEXUSTM). Earlier this year, FDA granted NEXUSTM designation as a […]
