Stereotaxis gains FDA approval for new robotically navigated cardiac ablation catheter
Stereotaxis, a St. Louis-based medtech company, has received U.S. Food and Drug Administration (FDA) approval for a new robotically navigated magnetic ablation catheter built to perform minimally invasive radiofrequency cardiac ablations on patients with complex arrhythmias.
The Magic Magnetic Interventional Ablation Catheter was designed to work with Stereotaxis robotic magnetic navigation systems. Electrophysiologists guide it through the use of computer-controlled magnetic fields, providing high levels of maneuverability, precision and stability. Key features include a rounded ablation tip, a helical fluid channel that delivers consistent cooling and magnets specifically designed to improve navigation.
The FDA’s approval of this device covers cardiac electrophysiological mapping, the delivery of diagnostic pacing stimuli and the treatment of supraventricular tachycardia in high-risk patients with congenital heart disease.
“FDA approval of Magic is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology,” David Fischel, Stereotaxis chairman and CEO, said in a statement. “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.”
“Robotic magnetic navigation has played a central role in the treatment of complex arrhythmias, and 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,” added Peter Weiss, MD, a cardiac electrophysiologist and associate professor of medicine at Banner University of Arizona Medical Center.
In July 2025, Stereotaxis secured FDA clearance for another robotically navigated electrophysiology device, the Magic Sweep catheter.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.