The Latest Cardiac and Vascular News
TAMPA, Florida, May 2, 2019 /PRNewswire/ — Concept Medical Inc. (CMI) has been granted “Breakthrough Device Designation” from the U.S. Food and Drug Administration (FDA) for MagicTouch, its Sirolimus drug-coated balloon (DCB) catheter, for the treatment of coronary in-stent restenosis (ISR). In-stent restenosis (ISR) is the gradual re-narrowing of a stented coronary artery lesion, due to […]
DANVERS, Mass.–(BUSINESS WIRE)–Abiomed (NASDAQ: ABMD) announces that, on April 26, the FDA approved initiation of the ST-Elevation Myocardial Infarction Door-to-Unloading (STEMI DTU) Pivotal Randomized Controlled Trial. The prospective, multi-center, two-arm trial plans to enroll 668 patients undergoing treatment for a STEMI heart attack. Half the patients will be randomized to receive […]
DUBLIN – May 2, 2019 – Medtronic plc (NYSE:MDT) today announced that the company has received U.S. Food and Drug Administration (FDA) approval for the CareLink SmartSync(TM) Device Manager. With the introduction of SmartSync, physicians will now be able to use an Apple® iPad® to program and manage data from Medtronic’s BlueSync-enabled […]
SAN DIEGO–(BUSINESS WIRE)–Sotera Wireless, maker of the ViSi Mobile® Surveillance Monitoring System will be exhibiting at the Institute for Healthcare Improvement Patient Safety Congress (IHI) on May 15-17 in Houston, TX. The IHI Patient Safety Congress brings together people who are passionate about providing the highest quality care and patient […]
WESTMINSTER, Colo., May 01, 2019 (GLOBE NEWSWIRE) — ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically-targeted therapies for cardiovascular diseases, today announced that the paper “GENETIC-AF: Bucindolol for the Maintenance of Sinus Rhythm in a Genotype-Defined Heart Failure Population” was published in JACC: Heart Failure, a journal […]
BOSTON, April 30, 2019 /PRNewswire/ — Biofourmis announced today that the U.S. Food and Drug Administration (FDA) has granted the company clearance for its RhythmAnalyticsTM platform, a cloud-based software for automated interpretation of cardiac arrhythmias. It uses an enhanced deep-learning technique to detect over 15 types of cardiac arrhythmias along with beat-by-beat morphology computation which […]
ENGLEWOOD, Colo., April 30, 2019 /PRNewswire/ — Zynex, Inc. (NASDAQ: ZYXI), an innovative medical technology company specializing in the manufacture and sale of non-invasive medical devices for pain management, stroke rehabilitation, cardiac monitoring and neurological diagnostics, today reported financial results for its first quarter ended March 31, 2019. First Quarter Financial Results Summary:For the first […]
LAKE FOREST, Ill., May 1, 2019 /PRNewswire/ — Omron Healthcare, Inc., the number one doctor and pharmacist recommended blood pressure brand, today launched Complete™, the first blood pressure monitor with EKG capability in a single device, for retail sale in the U.S. online at OmronHealthcare.com. Complete recently received FDA clearance as a medical device. […]
ATLANTA, April 30, 2019 /PRNewswire/ — First Quarter and Recent Business Highlights: Total revenues were $67.5 million in the first quarter of 2019, reflecting year over year growth of 9% and an 11% increase on a non-GAAP constant currency basis, both compared to the first quarter of 2018 On-X® revenues increased 14%, and 15% on […]
LONDON–(BUSINESS WIRE)–LivaNova PLC (NASDAQ:LIVN), a market-leading medical technology and innovation company, today reported results for the quarter ended March 31, 2019. For the first quarter of 2019, worldwide sales from continuing operations were $250.8 million, an increase of 0.2 percent on a reported basis and an increase of 4.2 percent on […]
