Vancouver’s Kardium just cleared a major milestone: the U.S. Food and Drug Administration (FDA) has approved its Globe Pulsed Field System, a medical device designed to treat atrial fibrillation (AFib)—a common and potentially dangerous heart rhythm disorder.

The system uses a technique called pulsed field ablation (PFA), which treats AFib by delivering short electrical pulses to precisely target the heart tissue causing irregular rhythms. Unlike traditional ablation methods that rely on heat or freezing, PFA is faster and less likely to damage surrounding tissue.

“FDA approval opens the door for U.S. patients to access safer, more effective treatment for atrial fibrillation,” said Kardium CEO Kevin Chaplin in a release.

The win caps off a big year for Kardium. In February, the company raised $340 million CAD to expand manufacturing and secure regulatory approvals for the Globe system. The round was one of the largest ever for a Canadian medical device startup, underscoring the global potential of the technology.

AFib affects millions worldwide and is a growing health challenge as populations age. Kardium’s entry into the U.S. market positions it at the forefront of a shift toward pulsed field ablation, a method many experts see as the future of cardiac care.

For Vancouver’s tech and life sciences community, it’s another example of local innovation achieving global impact—this time in the operating room.