The Latest Cardiac and Vascular News
VANCOUVER, Aug. 21, 2017 /PRNewswire/ – Cardiome Pharma Corp. (NASDAQ: CRME/ TSX:COM) today announced that it has received a response from the U.S. Food and Drug Administration (FDA) regarding the regulatory path for BRINAVESS® (vernakalant hydrochloride, IV), the Company’s antiarrhythmic drug for the rapid conversion of recent onset atrial fibrillation (AF). In its […]
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, Cardiology, Surgery, Patient ISSUE: Cook Medical Inc. is recalling the […]
SINGAPORE, July 31, 2017 /PRNewswire/ — QT Vascular Ltd., together with its subsidiaries (the “Company”), announced it has started enrollment in its United States (“US“) pivotal clinical study. The study will evaluate the Company’s drug coated balloon (“DCB“), the Chocolate Touch®, for use in superficial femoral and popliteal arteries with the intention of obtaining […]
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. Fractured pieces of the delivery wire could be left inside […]
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 II Below the Knee (TOBA II BTK) clinical trial from 12 months to […]
FREMONT, Calif. and OXFORD, United Kingdom, July 6, 2017 /PRNewswire/ — Cerus Endovascular Ltd. today announced that it has received CE Mark approval for the commercial sale of its Contour Neurovascular System for the treatment of intra-cranial aneurysms (IAs) across the European Union (EU). The Contour Neurovascular System is a unique, fine mesh braid […]
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 ambulatory ECG monitoring recordings. The Cardiologs system is also CE-marked […]
REDWOOD CITY, Calif.–(BUSINESS WIRE)–HeartFlow, Inc. today announced that the American Medical Association (AMA) has issued a set of new Category III Current Procedural Terminology (CPT®) codes for HeartFlow® FFRct, a first-of-its-kind noninvasive technology that helps clinicians diagnose and treat patients with suspected coronary artery disease (CAD). The CPT code application was submitted […]
IRVINE, Calif., July 5, 2017/PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, today announced it received U.S. Food and Drug Administration (FDA) approval for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves. […]
NEWS PROVIDED BY USC Center for Body Computing 11:51 ET WASHINGTON, June 30, 2017 /PRNewswire-USNewswire/ — This week in the nation’s capital the Bipartisan Policy Centerconvened thought leaders in national security and health care including Leslie Saxon, MD, cardiologist at Keck Medicine of USC and executive director of the USC Center for Body Computing, for a panel discussion, “Cybersecurity and […]
