The Latest Cardiac and Vascular News
KFAR-SABA, Israel & ALISO VIEJO, Calif.–(BUSINESS WIRE)–CathWorks announced today that its FFRangio™ System received United States Food & Drug Administration (FDA) 510(k) clearance. The FFRangio system demonstrated accuracy versus the invasive FFR wire in a blinded comparative study, FAST-FFR. The results of the FAST-FFR pivotal study were used to establish substantial […]
LAVAL, Québec, Dec. 20, 2018 (GLOBE NEWSWIRE) — Acasti Pharma Inc. (“Acasti or the “Company”) (NASDAQ: ACST – TSX-V: ACST), a biopharmaceutical innovator focused on the research, development and commercialization of its prescription drug candidate CaPre® (omega-3 phospholipid) for the treatment of severe hypertriglyceridemia (HTG), today announced it has reached […]
BRAINTREE, Mass.–(BUSINESS WIRE)–Paragonix Technologies, Inc. today announced that it received clearance by the Food and Drug Administration (FDA) for a design enhancement allowing for the use of the Paragonix SherpaPak™ Cardiac Transport System (CTS)1,2 with small and pediatric donor hearts. Starting in Q1 2019, Paragonix SherpaPak™ CTS will now be shipped with […]
LONDON and MONTREAL, Dec. 17, 2018 (GLOBE NEWSWIRE) — DalCor today announced the completion of patient enrollment in the dal-GenE study, the first Phase 3 precision medicine cardiovascular outcomes trial in coronary heart disease. The dal-GenE study is evaluating the efficacy of the CETP inhibitor dalcetrapib to reduce clinical cardiovascular […]
GALWAY, Ireland–(BUSINESS WIRE)–WhiteSwell, a company pioneering new ways to treat acute decompensated heart failure, today announced the close of a $30 million series B funding round led by RA Capital Management and an InCube Ventures syndicate, with participation from other investors. Funds from the round will be used to support […]
ALAMEDA, Calif.–(BUSINESS WIRE)–Singulex announced today the granting of a significant European patent (EP 3168618) covering methods for determining myocardial infarction using any high sensitivity cardiac troponin assay with a sensitivity < 5 pg/mL. “The global clinical market is rapidly adopting high sensitivity cardiac troponin assays to better manage patients suspected […]
MARLBOROUGH, Mass., Dec. 11, 2018 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) today announced that a jury in the United States (U.S.) District Court for the District of Delaware determined that the Boston Scientific U.S. patent 8,992,608 is valid and that Edwards Lifesciences’ Sapien 3™ Aortic Valve infringes this patent and that Edwards owes Boston Scientific infringement damages […]
IRVINE, Calif., Dec. 11, 2018 /PRNewswire/ — Edwards Lifesciences Corporation (NYSE: EW), the global leader in patient-focused innovations for structural heart disease and critical care monitoring, commented today on a federal jury’s decisions in patent litigation between Edwards and Boston Scientific: The jury awarded $35 million in damages to Boston Scientific for infringement of U.S. […]
GALWAY, Ireland, Dec. 12, 2018 /PRNewswire/ — An Irish medical device’s company, AuriGen Medical has won the prestigious Global Innovation Award at the ICI conference in Tel Aviv, Israel. ICI is the premier International Conference for Innovations in Cardiovascular Systems. The Global Innovation award attracted entries from the best medical device and pharmaceutical start-ups from […]
RESEARCH TRIANGLE PARK, N.C. & TORONTO–(BUSINESS WIRE)–Analytics 4 Life, a digital health company dedicated to improving existing diagnostic pathways, and Actelion Pharmaceuticals Ltd., today announced a collaborative agreement to investigate the use of Analytics 4 Life’s diagnostic imaging technology in pulmonary hypertension. The first 500-person clinical study has been initiated […]
