The U.S. Food and Drug Administration (FDA) has cleared the ARTIS icono, a high-precision family of angiography systems from Siemens Healthineers that permit a wide range of minimally invasive procedures to be performed in a single interventional suite. ...
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AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Fast Track designation for the development of FARXIGA (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF)....
Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced that the one-year data from its Tack Optimized Balloon Angioplasty (TOBA) III clinical trial will be presented during the High Impact Clinical Research session of the 31st...
Amarin Corporation plc (NASDAQ: AMRN), a pharmaceutical company focused on improving cardiovascular health, today announced that the National Lipid Association (NLA) has issued a position statement recognizing the cardiovascular risk-lowering effects of icosapent ethyl based on the landmark REDUCE-IT cardiovascular outcomes study....
Celgene Corporation (NASDAQ: CELG) today announced top-line results from the international phase 3, randomized, double-blind, placebo-controlled study, QUAZAR AML-001. The study evaluated the efficacy and safety of investigational therapy CC-486 as maintenance therapy in patients with newly diagnosed acute myeloid leukemia (AML) ...
CUTERA, INC., (Nasdaq: CUTR) ("Cutera" or the "Company") a leading provider of laser, light and other energy-based aesthetic systems for practitioners worldwide, announced today that Health Canada recently granted regulatory approval expanding the indications...
HeartFlow, Inc. today announced that it has obtained clearance from the U.S. Food and Drug Administration (FDA) for the HeartFlow Planner, a non-invasive, real-time virtual modeling tool for coronary artery disease (CAD) intervention....
Apple today announced three unprecedented medical studies, in partnership with leading academic and research institutions, that will reach more participants than has ever been possible. The studies will be available on the new Research app,1 which democratizes how medical research is conducted by bringing together academic medical institutions...
Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for neratinib...