The Latest Cardiac and Vascular News
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 […]
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 (ESRD) patients requiring hemodialysis. The FDA’s action will provide U.S. […]
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 (“FDA”) has granted regenerative medicine advanced therapy (“RMAT”) designation to […]
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 Graft System (INCRAFT). The panel voted 11 to 4 in […]
Stratford-upon-Avon, UK, 08 June 2018 – Celixir, a privately owned company discovering and developing life-saving advanced therapies, announces that the US Food and Drug Administration (FDA) has approved its Investigational New Drug application (IND) for HeartcelTM, its immuno-modulatory progenitor (iMP) cell therapy for the treatment of adult heart failure. Celixir announced […]
