The Latest Cardiac and Vascular News
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 […]
Fast Track Designation Highlights the Urgent Need for New Heart Failure Treatment Options THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif., May 8, 2020 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Cytokinetics, Incorporated (NASDAQ:CYTK) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for omecamtiv mecarbil, a novel selective cardiac myosin […]
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. […]
PORTLAND, Ore., April 23, 2020 /PRNewswire/ — VisCardia Inc., a privately held medical device developer, announced today it has been granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its implantable VisONE® system designed for the treatment of moderate to severe heart failure with reduced ejection fraction and preserved ventricular […]
Endospan is Granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for the NEXUS™ Aortic Arch Stent Graft System. HERZLIA, Israel–(BUSINESS WIRE)–Endospan, a pioneer in off-the-shelf endovascular repair of aortic arch disease was recently granted Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for […]
Swedish Heart-Lung Home Monitor Expands Indications for use in COVID-19 Respiratory Diagnostic Exams IRVINE, Calif., April 15, 2020 /PRNewswire/ — Coala Life, a leading Swedish digital health company has, as supported by FDA’s Emergency Guidance, expanded the indication for use enabling physicians to remotely, in real-time, monitor patients’ hearts and lung sounds. The Coala […]
Intact Vascular’s Tack Endovascular System is a First-of-its-Kind Vascular Implant for Optimized Balloon Angioplasty Outcomes in Challenging CLI Patient Population WAYNE, Pa.–(BUSINESS WIRE)–Intact Vascular, Inc., a developer of medical devices for minimally invasive peripheral vascular procedures, today announced it received U.S. Food and Drug Administration (FDA) approval for the Tack […]
MONMOUTH JUNCTION, N.J., April 13, 2020 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat cytokine storm and deadly inflammation in critically-ill and cardiac surgery patients around the world, announced the United States Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) of CytoSorb® for use in patients with COVID-19 […]
