The Latest Cardiac and Vascular News
WHIPPANY, N.J., July 15, 2019 /PRNewswire/ — Bayer announced today the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients […]
ABBOTT PARK, Ill., July 15, 2019 /PRNewswire/ — Abbott (NYSE: ABT) today announced the company has received U.S. Food and Drug Administration (FDA) approval for the most advanced MitraClip™ heart valve repair device to treat mitral regurgitation. The latest approval for the fourth-generation MitraClip […]
LAKE OSWEGO, Ore., July 8, 2019 /PRNewswire/ — BIOTRONIK today announced FDA clearance of the BIOMONITOR III injectable cardiac monitor (ICM). BIOMONITOR III is designed to document suspected arrhythmia or unexplained syncope with increased clarity, enabling fast diagnosis and appropriate treatment. Early detection of arrhythmia through […]
SCOTTSDALE, Ariz., June 28, 2019 /PRNewswire-PRWeb/ — Innovative Health, the leading single-use cardiology medical device reprocessing company, today announced it has received FDA clearance for reprocessing the market-leading PENTARAY® Nav eco High-Density mapping catheter (hereinafter PentaRay), a development that represents both a technological […]
MT. OLIVE, N.J., June 26, 2019 /PRNewswire/ — Catheter Precision, Inc., announced today that the U.S. Food and Drug Administration (FDA) has cleared its new VIVO™ (View into Ventricular Onset) system for market release in the United States. VIVO is a pre-procedure planning […]
WASHINGTON, June 24, 2019 /PRNewswire/ — The Centers for Medicaid and Medicare Services last Friday issued their final National Coverage Decision on how hospitals will be approved to do the TAVR (transaortic valve replacement) procedure, a less invasive valve replacement treatment that avoids […]
WILMINGTON, Mass., June 24, 2019 /PRNewswire/ — Micro Medical Solutions (MMS), an innovator in the field of microvascular interventions that improve clinical outcomes and quality of life, announced today that it has received Investigational Device Exemption (IDE) approval from the U.S. Food […]
LEXINGTON, Mass. and BOTHELL, Wash., June 21, 2019 /PRNewswire/ — (Booth #500) — Fujifilm will present its cardiovascular medical imaging portfolio including Synapse Cardiology PACS with Epsilon Imaging’s EchoInsight, as well as the SonoSite Edge II point-of-care-ultrasound system (POCUS) at the American Society of Echocardiography annual meeting (ASE 2019). The […]
FRANKLIN LAKES, N.J., June 20, 2019 /PRNewswire/ — BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today issued the following statement following the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee […]
Amsterdam, the Netherlands – 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 Food and Drug Administration (FDA) has approved the company’s premarket approval (PMA) application for […]
