ST. LOUIS, Missouri — January 6, 2026 — Leads & Copy — Stereotaxis (NYSE: STXS) announced it has secured U.S. Food and Drug Administration (FDA) approval for its MAGiC™ Magnetic Interventional Ablation Catheter.
According to Stereotaxis Chairman and CEO David Fischel, the FDA approval is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. He said the approval ensures the benefits of Robotic Magnetic Navigation can support patients with complex and critical heart rhythm disorders. Fischel added that it represents a major advance in robotic cardiac ablation technology and provides a foundation for continued technological and clinical progress.
Stereotaxis’ MAGiC catheter is a robotically-navigated magnetic ablation catheter designed to perform cardiac ablation procedures that treat heart arrhythmia. The catheter is designed to expand access to minimally-invasive cardiac ablation therapy in complex underserved patient populations. The catheter is navigated by highly-precise computer-controlled magnetic fields, offering levels of catheter maneuverability, precision and stability often not possible with traditional catheters.
Cardiac Electrophysiologist and Associate Professor of Medicine at Banner University of Arizona Medical Center, Dr. J. Peter Weiss, said Robotic Magnetic Navigation has played a central role in the treatment of complex arrhythmias. He added that FDA approval of MAGiC is a critical milestone in the advancement of the technology and ensuring its continued positive impact on the care of challenging electrophysiology patients.
Cardiac Electrophysiologist, Texas Cardiac Arrhythmia Institute at St. David’s Medical Center, Dr. J. David Burkhardt, said the MAGiC catheter is an important innovation in the robotic treatment of arrythmias. He added that it will support efforts to offer safe and effective therapy to otherwise underserved patients, and that he looks forward to using MAGiC and its unique advantages to continue pioneering the leading edge of electrophysiology.
The MAGiC Magnetic Interventional Ablation Catheter is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and for the creation of endocardial lesions to treat supraventricular tachycardia (e.g., macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia) in patients with congenital heart disease in whom vascular or target chamber access by conventional manual catheter navigation is limited due to underlying anatomic abnormalities and/or previous surgical interventions.
Stereotaxis is a pioneer and global leader in innovative surgical robotics for minimally invasive endovascular intervention. Its mission is the discovery, development and delivery of robotic systems, instruments, and information solutions for the interventional laboratory. Stereotaxis technology has been used to treat over 150,000 patients across the United States, Europe, Asia, and elsewhere.
Stereotaxis Contacts:
David L. Fischel
Chairman and Chief Executive Officer
Kimberly Peery
Chief Financial Officer
314-678-6100
Investors@Stereotaxis.com
Source: Stereotaxis
