Stereotaxis has received the US Food and Drug Administration (FDA) approval for its MAGiC ablation catheter, permitting its use in cardiac ablation procedures.
The MAGiC Magnetic Interventional catheter is robotically navigated using computer-controlled magnetic fields. It is designed to conduct cardiac ablation procedures that treat various forms of arrhythmia.
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According to Stereotaxis, the catheter provides stability, manoeuvrability, and precision, not typically achievable with traditional catheters.
MAGiC is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and creating endocardial lesions for treating supraventricular tachycardia.
The robotically navigated catheter is intended for patients with congenital heart disease whose anatomical abnormalities or prior surgeries restrict access using conventional manual catheters.
Stereotaxis chairman and CEO David Fischel said: “FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology.
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By GlobalData“It ensures the benefits of robotic magnetic navigation can support patients with complex and critical heart rhythm disorders, represents a major advance in robotic cardiac ablation technology, and provides a foundation for continued technological and clinical progress.
“We want to thank and recognise the team members, partners, clinicians and reviewers who made this milestone possible. We look forward to seeing MAGiC serve as a key pillar in our effort to continue making robotics broadly impactful and beneficial in electrophysiology.”
Stereotaxis technology is used globally across various regions, including the US, Europe, and Asia. According to the company, more than 150,000 patients have been treated using its systems.
In January 2025, Stereotaxis won European CE mark approval for its MaGiC ablation catheter.
