Industry Press Releases
Abbott (NYSE: ABT) today announced the U.S. Food and Drug Administration (FDA) has approved updated labeling for the company’s HeartMate 3™ heart pump to be used in pediatric patients with advanced refractory left ventricular heart failure. With the updated labeling, physicians now have additional options for treating this underserved population awaiting a heart transplant or […]
EDEN PRAIRIE, MINN. (December 15, 2020) – ACIST Medical Systems, Inc., a Bracco Group Company, today announced a formal distribution partnership with Medis Medical Imaging to co-market in North America. This partnership is focused on Quantitative Flow Ratio (QFR®), a novel, non-invasive angiography based physiologic assessment of the presence and extent of coronary artery disease.
Tel Aviv, Israel – December 9, 2020 – SoniVie, an Israeli company developing a novel proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS) System to treat a variety of hypertensive disorders, today announced that it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the TIVUS System for renal artery denervation for […]
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has granted Abiomed (NASDAQ: ABMD) a 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 System™.
DUBLIN, Sept. 16, 2020 /PRNewswire/ — Medtronic plc (NYSE: MDT), the global leader in medical technology, today announced new data from the landmark WRAP-IT study, showing the TYRX™ Absorbable Antibacterial Envelope (TYRX Envelope) is cost-effective for patients at increased risk of infections who receive cardiac implantable electronic devices (CIEDs).
Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first and only intravascular image-guided, catheter-based system for diagnosis and treatment of patients with Peripheral Artery Disease (PAD), announced that the Company received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for its Ocelaris next-generation image-guided chronic total occlusion (CTO) crossing system.
Medtronic announced the U.S. Food and Drug Administration’s (FDA) approval of an early feasibility study (EFS) of the Intrepid™ Transcatheter Tricuspid Valve Replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation, a disease in which the diseased, damaged or malfunctioning tricuspid valve allows blood to flow back into the heart’s upper right chamber causing […]
ABBOTT PARK, Ill., Aug. 4, 2020 /PRNewswire/ — Abbott (NYSE: ABT) announced first enrollments in the TactiFlex PAF IDE study to evaluate a new device to treat people suffering from paroxysmal atrial fibrillation (PAF), a type of irregular heartbeat. The study will evaluate the performance of the investigational TactiFlex™ Ablation Catheter, Sensor Enabled™ (SE) for […]
Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) for the company’s HeartStart FR3  and HeartStart FRx  automated external defibrillators (AEDs), and their supporting accessories, including batteries […]
BIOTRONIK has today announced its commitment to giving physicians additional tools to pace in the His-Bundle, coinciding with the launch of its His-Bundle Pacing (HBP) tools in a limited number of centers starting now with a full launch later in 2020.
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