The Latest Cardiac and Vascular News
BRIDGEWATER, N.J. and TARRYTOWN, N.Y., Sept. 12, 2018 FDA also recently approved Praluent label update for some patients currently requiring LDL apheresis therapy /PRNewswire/ — Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted a supplemental Biologics License Application (sBLA) for Praluent® (alirocumab) Injection, a PCSK9 inhibitor. The […]
DUBLIN – September 11, 2018 – Today, Medtronic issued the following statement confirming it has received FDA warning letters (CMS #560736 and #562437) related to its Cardiac Rhythm and Heart Failure facilities located in Mounds View, Minn., and in Juncos, Puerto Rico. The warning letters reflect earlier FDA inspection reports from […]
MILFORD, Mass.–(BUSINESS WIRE)–Reprieve Cardiovascular™, a newly formed company affiliated with RenalGuard Solutions™, is a pioneering medical device company focused on improving outcomes for patients suffering from acute decompensated heart failure (ADHF). RenalGuard also announced the completion of a $7 million financing provided by strong support from existing investors and Abiomed, […]
TORONTO, Sept. 11, 2018 (GLOBE NEWSWIRE) — CellAegis Devices Inc. (“CellAegis” or the “Company”), a commercial-stage medical device company advancing innovative, non-invasive, safe and cost-effective solutions for acute and chronic cardiovascular conditions, today announced completion of patient enrollment in a large scale, investigator sponsored study (“FIRST”) to evaluate the clinical […]
TORONTO, Sept. 10, 2018 /PRNewswire/ – Baylis Medical Company, a leader in the development, manufacturing and commercialization of cardiology devices, announced the official commercial launch of its SureFlex® Steerable Guiding Sheath. The SureFlex sheath is part of Baylis’ rapidly growing portfolio of high-performance products for transseptal access. The sheath features an advanced sheath-to-dilator […]
SAN DIEGO, Sept. 11, 2018 /PRNewswire/ — Seqster the leading consumer-centric health data management platform empowering employees, members, or patients to collect, own and share all of their health data, today joined the American Heart Association’s Center for Health Technology and Innovation (CHTI) Health Tech Collaborative. The collaboration will combine AHA’s data-driven approaches with Seqster’s […]
BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc., a Boston-based commercial-stage medical device company, announced today, a successful series of clinical use, of the Paragonix SherpaPak™ Cardiac Transport System (CTS) at a leading Boston-based hospital and other world-renowned transplant centers in the United States and in Europe. The Paragonix SherpaPak™ CTS1,2 is intended for […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology company, welcomes the recently updated interventional procedures guidance for sutureless aortic valve replacement issued by the U.K. National Institute for Health and Care Excellence (NICE), which states that sutureless aortic valve replacement is an alternative to conventional surgical aortic valve replacement. The […]
SANTA CLARA, Calif.–(BUSINESS WIRE)–Ancora Heart, Inc., a company developing a novel therapy to address heart failure, today announced the company’s key activities at the 30th Transcatheter Cardiovascular Therapeutics (TCT), the annual scientific symposium of the Cardiovascular Research Foundation in San Diego. Interim data will be presented from the recently expanded […]
BRISBANE, Australia & CARLSBAD, Calif.–(BUSINESS WIRE)–ImpediMed Limited (ASX: IPD), a global provider of medical technology to non-invasively measure, monitor and manage tissue composition and fluid status using bioimpedance spectroscopy (BIS), announces that two abstracts demonstrating utilization of its SOZO® device will be presented during poster presentations by A.J. Accardi, M.D. at the upcoming American […]
