The Latest Cardiac and Vascular News
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 ICMs enables physician intervention before adverse outcomes occur. Atrial fibrillation […]
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 and healthcare cost reduction milestone. The PentaRay is a key […]
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 tool that offers 3D cardiac mapping to aid in localizing […]
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 open heart surgery and allows patients to resume daily life […]
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 and Drug Administration (FDA). IDE approval allows MMS to initiate […]
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 conference takes place June 21-25, 2019 at the Oregon Convention Center in Portland, OR. “At […]
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 meeting related to the potential increase in mortality associated with […]
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 its HeartStart OnSite defibrillator [1] and HeartStart Home defibrillator [2], […]
TUSTIN, Calif.–(BUSINESS WIRE)–Building on its advanced image reconstruction technologies, Canon Medical Systems USA, Inc. has received 510(k) clearance on its new deep convolutional neural network (DCNN) image reconstruction technology, ushering in a new era for CT. Canon Medical’s Advanced Intelligent Clear-IQ Engine (AiCE) uses a deep learning algorithm to differentiate signal from […]
CHICAGO–(BUSINESS WIRE)–TVT2019 – Structural Heart Summit — Materialise (NASDAQ:MTLS), a global 3D printing software and solutions company, has received FDA clearance for its Mimics Enlight cardiovascular planning software suite. The first release will support clinicians planning complex transcatheter mitral valve replacement (TMVR) procedures. Mimics Enlight is based on the strengths of […]
