The Latest Cardiac and Vascular News
Dr. Brajesh Lal of the University of Maryland Presents Study Data at the Society for Vascular Surgery Conference July 01, 2020 08:30 AM Eastern Daylight Time BOSTON–(BUSINESS WIRE)–Elucid Bio, maker of the FDA-cleared and CE-marked vascuCAP® software, announced today that […]
Amsterdam, the Netherlands and Cambridge, MA – Royal Philips (NYSE: PHG, AEX: PHIA), a global leader in health technology, today announced that the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) […]
CALGARY, Alberta, June 22, 2020 (GLOBE NEWSWIRE) — Resverlogix Corp. (“Resverlogix”) (TSX:RVX) is pleased to announce that the U.S. Food & Drug Administration (FDA) has accepted its BETonMACE2 clinical plan as a registration enabling study with positive implications for Resverlogix […]
DANVERS, Mass.–(BUSINESS WIRE)–The United States Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for Impella RP to include patients suffering from COVID-19 related right heart failure or decompensation, including pulmonary embolism (PE). Abiomed (NASDAQ: ABMD) manufactures Impella RP. Impella RP […]
WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation medical systems to treat ventricular tachycardia (VT), today announced that it has received Breakthrough Device Designation from the U.S. Food & Drug Administration (FDA) for its Saline Enhanced Radiofrequency (SERF) Ablation system and […]
New non-tapered metal-alloy catheter platform FDA cleared for use in peripheral vasculature PARK CITY, Utah, May 12, 2020 /PRNewswire/ — Transit Scientific announced the FDA cleared the XO Cross® Microcatheter platform for guidewire support, exchange, and contrast media injection in the peripheral vasculature. Microcatheters […]
MARLBOROUGH, Mass., May 12, 2020 /PRNewswire/ — CardioFocus, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved the next-generation HeartLight® X3 Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (PAF). Approval of the HeartLight X3 System […]
New large catheter platform FDA cleared to remove blood clots from peripheral vessels PARK CITY, Utah, May 6, 2020 /PRNewswire/ — Control Medical Technology announced the FDA cleared the Aspire MAX 7 – 11F Mechanical Thrombectomy platform to remove blood clots from peripheral […]
VitalPatch® wearable biosensor can monitor for heart-related side effects of Hydroxychloroquine and other COVID-19 treatments SAN JOSE, Calif., May 5, 2020 /PRNewswire/ — VitalConnect®, Inc., a leader in wearable biosensor technology, announced it was granted Emergency Use Authorization (EUA) status by the U.S. Food and […]
SAN CARLOS, Calif., April 30, 2020 (GLOBE NEWSWIRE) — BioCardia®, Inc. [Nasdaq: BCDA], a leader in the development of comprehensive solutions for cardiovascular regenerative therapies, today reported that it has accepted and implemented FDA-recommended modifications to the primary endpoint for the CardiAMP® […]
