Stereotaxis has won FDA approval for its robotically navigated MAGiC ablation catheter, offering a minimally invasive option for patients who otherwise might not be eligible for cardiac ablation to treat complex and critical heart rhythm disorders.
Related: Spectrumedics’ IVL catheter gains EU CE mark
MAGiC is short for “magnetic interventional ablation catheter,” an abbreviation Stereotaxis also uses for its FDA-cleared MAGiC Sweep robotically navigated high-density electrophysiology (EP) mapping catheter.
The St. Louis-based device developer’s MAGiC ablation catheter is designed for radiofrequency cardiac ablation to treat heart arrhythmia.
Specifically, the MAGiC ablation catheter’s indication covers cardiac electrophysiological mapping, delivering diagnostic pacing stimuli, and the creation of endocardial lesions to treat supraventricular tachycardia (SVT) in congenital heart disease patients of any age who have underlying anatomic abnormalities and/or a surgical history that limits vascular or target chamber access via conventional manual catheter navigation.
SVT includes macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia, and atrioventricular reentrant tachycardia.
Stereotaxis plans to launch the product in early 2026, CEO and Chair David Fischel said in a MassDevice interview ahead of the announcement.
“This is the first ablation catheter ever approved specifically for this indication, which is patients with complex congenital heart disease,” he said. “… FDA is showing that it’s approving devices for serious unmet medical need patients. It’s beautiful to see patients who typically don’t have good options receiving approved devices specifically suited for them.”
It’s also the first robotically steered ablation catheter approved in the U.S. in nearly two decades, he said, offering “a significant advantage” for electrophysiologists who are passionate about robotics.
“We think it’ll have a big impact on the community of underserved patients in the U.S. and the robotic electrophysiology community and we’re grateful for all of the engineers, clinicians, reviewers, everyone who made this possible,” Fischel said. “This is a very big milestone for us and for many people who will benefit from the technology.”
Robotic magnetic navigation has played a central role in the treatment of complex arrhythmias, said Dr. Peter Weiss, a cardiac electrophysiologist and a University of Arizona associate professor of medicine at Banner-University Medical Center Phoenix.
“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,” he said in a statement shared with MassDevice ahead of the announcement.
Stereotaxis secured European regulatory approval for the MAGiC device with a CE mark in January 2025. The device developer says its catheter navigation technology uses highly-precise computer-controlled magnetic fields for maneuverability, precision and stability that’s often not possible with traditional catheters.
Stereotaxis is working with CardioFocus on ways to combine that company’s pulsed-field ablation (PFA) technology with the MAGiC cardiac ablation catheter. PFA is a nonthermal method of cardiac ablation that appears to have fewer side effects and safety risks.
The MAGiC catheter’s FDA approval is the latest regulatory milestone for Stereotaxis, which won FDA 510(k) clearance for its next-generation GenesisX surgical robot in November 2025, a CE mark for its Synchrony system in October 2025, and FDA 510(k) clearance for its MAGiC Sweep catheter in July 2025.
Stereotaxis submitted the MAGiC Sweep catheter for FDA review in March 2025, around the same time that it filed a 510(k) submission with the FDA for its EMAGIN 5F device. The EMAGIN (an abbreviation of “endovascular magnetic intervention”) portfolio will include robotic catheters and wires, starting with the EMAGIN 5F (5 Fr diameter) catheter guide for robotic navigation of tortuous venous and arterial vasculature.
The company planned to launch EMAGIN 5F by the end of 2025 but does not yet appear to have won 510(k) clearance. The company did not share an update with MassDevice on that product.
