Tag: cardiofocus
CardioFocus submits HeartLight X3 PMA application to FDA
CardioFocus has submitted a pre-market approval (PMA) supplement to the US Food and Drug Administration (FDA) for the HeartLight X3 Endoscopic Ablation System for...
CardioFocus appoints Burke T Barrett as chief executive
CardioFocus, has announced that the company’s board of directors has promoted Burke T Barrett to the position of chief executive officer (CEO), effective January...
CardioFocus treats first patients with HeartLight endoscopic ablation system in France
CardioFocus has announced that the first patients in France have been treated in the University Public Hospital of Nancy with the HeartLight endoscopic ablation...
HeartLight expands its availability to more than 100 hospitals globally
The HeartLight Endoscopic Ablation System is now offered at more than 100 hospitals worldwide. CardioFocus highlighted the expanded availability of its catheter ablation technology...
Results announced from study with the HeartLight X3 system
CardioFocus recently announced the presentation of results from its pivotal confirmatory study evaluating the HeartLight X3 system for the treatment of AFib. The results...
Heartlight X3 gains European CE Mark
CardioFocus has announced the European CE Mark approval for its HeartLight X3 endoscopic ablation system, used in the treatment of atrial fibrillation.
The HeartLight X3 system...
CardioFocus completes enrolment in HeartLight X3 trial
CardioFocus has completed enrolment in a trial to evaluate its next-generation HeartLight X3 endoscopic ablation system. According to a press release, a total of...
FDA approval of the next-generation HeartLight Excalibur balloon designed for the...
The US Food and Drug Administration (FDA) has granted approval for the HeartLight Excalibur Balloon, a next-generation technology designed for the treatment of paroxysmal atrial...
CardioFocus announces initiation of HeartLight X3 clinical evaluation
CardioFocus have announced the initiation of a clinical evaluation of the new HeartLight X3 system for the treatment of AF.
Building upon the advanced features of the...
CE mark for CardioFocus’ Heartlight Excalibur balloon
CardioFocus’ HeartLight Excalibur Balloon has been granted CE mark. The technology is designed for the treatment of atrial fibrillation.
The Excalibur balloon builds on the...
CardioFocus receives approval for HeartLight Endoscopic Ablation System in Japan
CardioFocus has announced that the Japanese Ministry of Health, Labour and Welfare has approved the HeartLight Endoscopic Ablation System for the treatment of paroxysmal atrial fibrillation...
CardioFocus announces new management appointments
CardioFocus has announced the appointment of Omari Bouknight as chief commercial officer and Jeff Rynbrandt as vice president of US Sales. Together they will lead the commercialisation of...