The Latest Cardiac and Vascular News
MOUNTAIN VIEW, Calif., Sept. 10, 201 /PRNewswire/ — AliveCor, recently recognized as the Most Innovative Company in Artificial Intelligence, today announced that the U.S. Food and Drug Administration has given the company’s KardiaK Software Platform the rarely granted designation of “Breakthrough Device.” This designation means that the FDA will consider the technology […]
BLOOMINGTON, Ind.–(BUSINESS WIRE)–Cook Medical today announced that it received a close-out letter from the U.S. Food and Drug Administration resolving a 2014 warning letter for processes related to the quality system at the company’s manufacturing facility in Bloomington, Indiana. The resolution was a direct result of countless hours of hard […]
REDWOOD CITY, Calif., Aug. 30, 2018 (GLOBE NEWSWIRE) — Avinger, Inc. (NASDAQ:AVGR), a leading developer of innovative treatments for peripheral artery disease (PAD), today announced the Company submitted a new 510(k) application to the U.S Food & Drug Administration (FDA) for the Pantheris SV (Small Vessel) Lumivascular atherectomy system. Pantheris […]
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 Injection 50 mg/2 mL (25 mg/mL) single dose vial (“SNP”), […]
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 evaluate the safety and effectiveness of the Durablate catheter 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 is founded on Integer’s core technology platforms in guidewires and […]
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 by another ECG patch product to date. It deploys the […]
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 data used in the assessment of the risk for coronary […]
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. The HVAD System is the smallest commercially available LVAD, and […]
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 entire Access family of immunoassay systems. The Access hsTnI assay […]
