The Latest Cardiac and Vascular News
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) for the company’s HeartStart FR3 [1] and HeartStart FRx [2] […]
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 and its ongoing partnership discussions. Key written development points from […]
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 is a temporary heart pump that provides circulatory support for […]
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 Durablate® catheter. The FDA Breakthrough Devices Program is intended to help patients […]
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 are small 0.70-1.30mm outer diameter (OD) catheters used to provide guidewire […]
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 came as a result of a comprehensive submission, including outcomes […]
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 vessels. Blood clot removal (thrombectomy) is a common procedure. Coronary […]
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 Drug Administration (FDA) as part of the response to the […]
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® Cell Therapy Heart Failure Trial and associated statistical analysis plan. […]
WAYNE, Pa.–(BUSINESS WIRE)–Cagent Vascular, a developer of serration technology for vessel dilatation in cardiovascular disease interventions, announces FDA 510(k) Clearance of its Serranator® PTA Serration Balloon Catheter for treating below-the-knee (BTK) lesions. The Serranator device is the first and only angioplasty balloon FDA Cleared and CE Marked that embeds serration technology into a […]
