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BioWorld - Sunday, June 7, 2026
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Home » Kardium’s Globe PFA system gains FDA approval
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Kardium’s Globe PFA system gains FDA approval

Sep. 3, 2025
By Annette Boyle
Kardium Inc.’s Globe pulsed field system received U.S. FDA premarket approval, making it the fourth PFA system in the rapidly expanding market for cardiac ablation for atrial fibrillation. The system’s introducer sheath and mapping software also received clearance.
Medical technology Regulatory European Society of Cardiology Cardiovascular U.S. FDA PMA

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