The Latest Cardiac and Vascular News
Cook said to be recalling this device because of blood clots that can form within the graft after implantation. Zenith Alpha Thoracic Endovascular Graft by Cook Medical: Class I Recall – Potential Formation of Thrombus Inside Device AUDIENCE: Risk Manager, […]
AUSTIN, Texas–(BUSINESS WIRE)–BioStable Science & Engineering, Inc. announced today it has received FDA market clearance for the HAART 200 Aortic Annuloplasty Device, the first and only annuloplasty device designed specifically for bicuspid aortic valve repair. With FDA clearance of both […]
MOUNTAIN VIEW, Calif., Aug. 15, 2017 (GLOBE NEWSWIRE) — Vascular Dynamics, Inc., (VDI) a privately held medical device company developing novel solutions for the treatment of hypertension, today announces that the United States Food and Drug Administration (FDA) has approved […]
NORTHFIELD, MINNESOTA— AUM Cardiovascular announced that it has received clearance from the Food and Drug Administration for CADence,™ a non-invasive acoustic and ECG device designed to help physicians detect physiological and pathological heart murmurs. The reusable, non-invasive, radiation-free handheld device, […]
Penumbra Inc. Recalls 3D Revascularization Device Due to Wire Material That May Break or Separate During Use Penumbra Inc. is recalling the Penumbra 3D Revascularization device because there is a risk of the delivery wire breaking or separating during use. […]
WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced the U.S. Food and Drug Administration (FDA) approved an Investigational Device Exemption (IDE) supplemental application to modify the primary endpoint in the Tack Optimized Balloon Angioplasty […]
PARIS–(BUSINESS WIRE)–Cardiologs Technologies SAS announced today that it has received FDA clearance of its Cardiologs ECG Analysis Platform, a cloud-based cardiac monitoring-analysis web service powered by artificial intelligence (AI). Cardiologs aids physicians in screening for atrial fibrillation (AFib) and other arrhythmias using long-term […]
HONG KONG, June 6, 2017 /PRNewswire/ — Announcement marks company‘s official entry into the US market OrbusNeich, a global company specializing in the provision of life-changing vascular solutions, has announced the launch of its world-renowned Sapphire PTCA balloon dilatation catheters […]
IRVINE, Calif., June 5, 2017 — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it has received U.S. Food and Drug Administration (FDA) approval for aortic and mitral […]
NEW ORLEANS, La.–(BUSINESS WIRE)–Ra Medical Systems, makers of cardiovascular and dermatology catheters and excimer lasers, today announced the commercial launch in the United States of the Company’s groundbreaking DABRA™ System for the treatment of Peripheral Artery Disease. This follows FDA […]
