Kardium announced today that it completed the first commercial procedures using its Globe pulsed field ablation (PFA) system. These mark the first cases with Globe, a treatment for AFib, after its recent approval by the FDA. Last month, the FDA granted Globe premarket approval (PMA), plus 510(k) clearance for the Globe introducer sheath and Globe … [Read more...] about Kardium reports first commercial cases with Globe PFA
Kardium
Kardium gets FDA green light for Globe pulsed field ablation system
Kardium announced today that the FDA granted premarket approval (PMA) for its Globe pulsed field ablation (PFA) system. Along with the PMA, the FDA granted 510(k) clearance for the Globe introducer sheath and Globe pulsed field mapping software. With the FDA nod, Kardium joins the hot U.S. PFA market that includes major medtech names like … [Read more...] about Kardium gets FDA green light for Globe pulsed field ablation system
Kardium raises $250M to support pulsed field ablation system
Kardium announced today that it raised $250 million in a new financing round to support the launch of its pulsed field ablation system. New investors, including Janus Henderson Investors, Qatar Investment Authority (QIA), MMCAP, Piper Heartland Healthcare Capital, Eventide Asset Management and Eckuity Capital, led the oversubscribed round. … [Read more...] about Kardium raises $250M to support pulsed field ablation system
Kardium treats first patient in pulsed-field ablation study
Kardium announced today that it successfully treated the first patients in the PULSAR clinical study for its Globe PF pulsed-field ablation (PFA) system. Vancouver, British Columbia-based Kardium recently received FDA investigational device exemption (IDE) to conduct the study. The international, multicenter PULSAR study evaluates the safety and … [Read more...] about Kardium treats first patient in pulsed-field ablation study
