The Latest Cardiac and Vascular News
JUNE 28, 2017 BY KEN DROPIEWSKI (KEN@PRIME-CORE.COM) Real-time information is critical while performing a procedure. Doctors often require data from outside sources to proceed in a difficult situation. But obtaining such information during an intervention can be problematic and may even place the patient at risk. Augmented reality (AR) is one technology that […]
ANAHEIM, Calif.–(BUSINESS WIRE)–ClearFlow, Inc., a medical device company based in Anaheim, California, announced today that the United States Food & Drug Administration (FDA) has granted 510[k] clearance for the company’s proprietary FlowGlide™ Active Clearance Technology® System. “The new design helps resist kinks, and allows positioning of the catheters into harder-to-reach […]
BARCELONA, Spain–(BUSINESS WIRE)–There is an industrywide drive toward a unified clinical operating model, according to the Veeva 2017 Unified Clinical Operations Survey, one of the industry’s largest annual surveys of clinical operations professionals. The new research from Veeva Systems (NYSE: VEEV) reveals that nearly all respondents cite the need to […]
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of next generation technology for vessel dilatation in cardiovascular disease interventions, including the FDA 510(k) cleared Serranator® Alto PTA Serration Balloon Catheter, announces the completion of enrollment in the First-in-Human PRELUDE Study. The purpose of this prospective, single-arm, multicenter feasibility study is to show […]
GlobalNewsWire DUBLIN – May 24, 2017 – Medtronic plc (NYSE: MDT) today announced that the first patient has been enrolled in the IN.PACT(TM) AV Access Drug-Coated Balloon (DCB) study for use in patients with end-stage renal disease (ESRD). The U.S. Food and Drug Administration (FDA) approved the investigational device exemption […]
FREMONT, Calif.–(BUSINESS WIRE)–Shockwave Medical, a pioneer in the treatment of calcified cardiovascular disease, today announced conformité européenne (CE) Mark for the company’s Coronary Lithoplasty® System for the treatment of calcified plaque in conjunction with stenting in patients with coronary artery disease. The Shockwave Medical Coronary Lithoplasty System is an innovative […]
TAIPEI, Taiwan, May 2, 2017 /PRNewswire/ — Medeon Biodesign, Inc., a Taiwan publically traded medical device company, is pleased to announce today that it has received approval by the Health and Disability Ethics Committees, Ministry of Health, New Zealand to commence the CE clinical trial for the XProTM Suture-Mediated Vascular […]
CARLSBAD, Calif.–(BUSINESS WIRE)–Acutus Medical®, a company committed to transforming the lives of millions of patients with complex arrhythmias, today announced the FDA clearance of the AcQGuide™ Steerable Sheath. The company will also feature several international presentations highlighting the AcQMap® High Resolution Imaging and Mapping System at the Heart Rhythm Society’s […]
Teleflex Receives FDA 510(k) Clearance for the Arrow® AC3 OptimusTM Intra-Aortic Balloon Pump (IABP) Advanced IABP performance with the ability to provide optimized therapy to the most challenging patient conditions, even patients with the most severe arrhythmias and heart rates as high as 200 bpm.1 WAYNE, Pa.–(BUSINESS WIRE)–Teleflex Incorporated (NYSE: […]
HANGZHOU, China, April 28, 2017 /PRNewswire/ — Venus Medtech (Hangzhou) Inc., announced on April 25th that its transcatheter aortic valve system – Venus A-valve – has been approved by China Food and Drug Administration(“CFDA”) (registration no.: 20173460680) for sale in China. This marks the first-ever CFDA approved Transcatheter Aortic Valve Implantation […]
