The Latest Cardiac and Vascular News
WINNIPEG, Aug. 13, 2018 /PRNewswire/ – Medicure Inc. (“Medicure” or the “Company”) (TSXV:MPH, OTC:MCUJF), a cardiovascular pharmaceutical company, is pleased to announce that the United States Food and Drug Administration (“FDA”) has approved its Abbreviated New Drug Application (“ANDA”) for Sodium Nitroprusside […]
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical® announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) application for the Early Feasibility Study (EFS) of the groundbreaking Durablate™ ablation catheter. The single-arm, observational study is designed to […]
PLYMOUTH, Minn., July 31, 2018 (GLOBE NEWSWIRE) — Integer Holdings Corporation (“Integer”) (NYSE:ITGR), a leading medical device outsource manufacturer, announced today that it has received FDA and CE Mark approval for their new radial access introducer, RadialSeal™. The RadialSeal Introducer Kit […]
FREMONT, Calif.–(BUSINESS WIRE)–LifeSignals announced today that it received FDA clearance for its wireless LP1100 Life Signal Patch for enabling the next generation of wearable, healthcare monitoring devices. It is built on two solid technology foundations to provide unprecedented attributes unachieved […]
SHEFAYIM, Israel–(BUSINESS WIRE)–Zebra Medical Vision (http://zebra-med.com/) announces today it has received 510(k) clearance for its Coronary Calcium Scoring algorithm. The algorithm, capable of automatically calculating a patient’s Agatston equivalent coronary calcium score from ECG gated CT scan, provides physicians with important […]
DUBLIN – July 11, 2018 – Medtronic plc (NYSE: MDT) has received United States Food and Drug Administration (FDA) approval for a less-invasive implant approach of its HVAD(TM) System, a left ventricular assist device (LVAD) for patients with advanced heart failure. […]
BREA, Calif., June 27, 2018 /PRNewswire/ — Beckman Coulter Diagnostics announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its new high-sensitivity troponin (hsTnI) assay, Access hsTnI, for use on the Access 2, DxI and the […]
SAN JUAN CAPISTRANO, Calif.–(BUSINESS WIRE)–Avenu Medical, Inc. announced today that it has received De Novo marketing authorization from the Food and Drug Administration (FDA) to market its Ellipsys® Vascular Access System, an innovative, minimally-invasive catheter-based system designed for End-Stage Renal Disease […]
BASKING RIDGE, N.J., June 19, 2018 (GLOBE NEWSWIRE) — Caladrius Biosciences, Inc. (Nasdaq:CLBS) (“Caladrius” or the “Company”), a clinical-stage biopharmaceutical company with multiple technology platforms targeting select cardiovascular indications and autoimmune diseases, announces today that the U.S. Food and Drug Administration […]
DUBLIN, Ohio, June 12, 2018 /PRNewswire/ — Cardinal Health (NYSE: CAH) today announced that the U.S. Food and Drug Administration (FDA) Circulatory System Devices Panel of the Medical Devices Advisory Committee has provided a favorable recommendation on the premarket approval application for INCRAFT® AAA Stent […]
