The Latest Cardiac and Vascular News
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 […]
Data presented at HRS 2020 shows Cardiologs’ AI-system successfully eliminates more than two-thirds of atrial fibrillation false positives from ILR reports, alleviating the clinical burden associated with remote monitoring PARIS and BOSTON, May 14, 2020 /PRNewswire/ — Cardiologs, a global leader in artificial intelligence (AI) for cardiac diagnostics, today in partnership with the Valley Health […]
Developed with Mayo Clinic, the algorithm helps identify low ejection fraction – a sign of heart failure and a significant comorbidity for COVID-19 patients OAKLAND, Calif.–(BUSINESS WIRE)–Eko, a digital health company building AI-powered screening and telehealth solutions to fight cardiovascular disease, today announced that the U.S. Food and Drug Administration […]
WATERTOWN, Mass., May 12, 2020 /PRNewswire/ — Affera, Inc., a private medical device company focused on innovative cardiac arrhythmia treatment solutions, announced today that its platform was featured prominently in scientific sessions at the Heart Rhythm Society 2020 (HRS) meeting held online May 6-9. Simultaneously, three manuscripts describing pre-clinical experiments and clinical trials […]
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 […]
Malmö, Sweden May 11, 2020 Last patient included in Acarix’s exploratory heart failure study SEISMO Acarix AB (publ) today announced that the last patient has been included in the exploratory SEISMO study on a potential heart failure application. The exploratory clinical heart failure trial SEISMO was initiated in June 2018 to evaluate the possibility […]
MENLO PARK, CA, May 7, 2020 /PRNewswire/ – FARAPULSE Inc. (“FARAPULSE” or “the Company”) and its pulsed field ablation (PFA) technology for Atrial Fibrillation featured heavily in the collection of science published online by the Heart Rhythm Society in lieu of an annual meeting. Highlights of the data presented by the investigators from seven […]
Trial meets primary safety and efficacy endpoints with low complication rates, 100% effective closure with next-generation stroke risk reduction technology for patients with non-valvular atrial fibrillation MARLBOROUGH, Mass., May 8, 2020 /PRNewswire/ — Today, Boston Scientific (NYSE: BSX) announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy […]
Results Suggest Highly Effective Method to Treat Ventricular Tachycardia, a Leading Cause of Sudden Cardiac Death WALTHAM, Mass.–(BUSINESS WIRE)–Thermedical®, a developer of thermal-ablation systems to treat ventricular tachycardia (VT), announced that results from a First-in-Human Early Feasibility Study (EFS) using the new Durablate® catheter to treat VT were presented in […]
Results presented virtually via Heart Rhythm 365 Platform; study met primary effectiveness endpoint of superiority in favor of the hybrid Convergent procedure MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in treatments for atrial fibrillation (Afib) and left atrial appendage (LAA) management, today announced the results from the CONVERGE […]
