CardioFocus, Inc., a medical device company, dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the Japanese Ministry of Health, Labor and Welfare (“MHLW”) has approved the company’s HeartLight X3 System for marketing in Japan.
MARLBOROUGH, Mass., June 16, 2020 /PRNewswire/ — CardioFocus, Inc., today announced that the first U.S. patients have been treated commercially with the recently-approved HeartLight X3 Endoscopic Ablation System. The revolutionary cardiac ablation technology is designed to treat drug refractory, symptomatic paroxysmal atrial fibrillation (AFib), the most common heart rhythm disorder.
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 symptomatic paroxysmal atrial fibrillation (PAF).
MARLBOROUGH, Mass., February 4, 2020 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced that the company has submitted a pre-market approval (PMA) supplement to the U.S. Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for the treatment of AFib. This supplement follows the original, approved PMA of the HeartLight Endoscopic System. U.S. commercial launch of the HeartLight X3 System will immediately follow approval of the PMA supplement.
MARLBOROUGH, Mass., January 22, 2020 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that the Company’s Board of Directors has promoted Burke T. Barrett to the position of Chief Executive Officer (CEO), effective January 19, 2020. Mr. Barrett previously served as CardioFocus’ President and Chief Operating Officer (COO).
MARLBOROUGH, Mass., October 29, 2019 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that the first patients in France have been treated at the Centre Hospitalier Régional Universitaire (CHRU) of Nancy with the HeartLight® Endoscopic Ablation System as part of an exclusive distribution partnership with MicroPort CRM France.
MARLBOROUGH, Mass., June 18, 2019 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), announced today that the HeartLight® Endoscopic Ablation System is now offered at more than 100 hospitals worldwide.
MARLBOROUGH, Mass., May 28, 2019 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced the completion of a $55 million round of financing.
MARLBOROUGH, Mass., May 10, 2019 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3 System for the treatment of AFib.
MARLBOROUGH, Mass., Mar. 25, 2019 /PRNewswire/ — CardioFocus, Inc., a medical device company dedicated to advancing ablation treatment for atrial fibrillation (AFib), today announced the European CE Mark approval of the HeartLight X3 Endoscopic Ablation System.