FDA Approves Stereotaxis' MAGiC Robotic Ablation Catheter for Congenital Heart Patients

The US Food and Drug Administration has approved Stereotaxis' MAGiC Magnetic Interventional Ablation Catheter, a catheter steered by computer-controlled magnetic fields, for treating abnormal heart rhythms in patients with congenital heart disease, the St. Louis company announced on January 6 in a release distributed by GlobeNewswire, read via Finviz.

The FDA's premarket approval database lists the device as P240014, a cardiac ablation percutaneous catheter. The agency received the application on April 12, 2024, and issued its decision on January 5, 2026. The record shows the application did not receive expedited review and was handled by the cardiovascular advisory committee panel.

A narrow indication

The approval covers cardiac electrophysiological mapping, diagnostic pacing and the creation of endocardial lesions to treat supraventricular tachycardia, including macroreentrant atrial tachycardia, focal atrial tachycardia, atrioventricular nodal reentrant tachycardia and atrioventricular reentrant tachycardia. It is limited to 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," according to the database entry.

Stereotaxis said the catheter is guided by its Robotic Magnetic Navigation technology and is "designed to expand access to minimally-invasive cardiac ablation therapy in complex underserved patient populations." The company said the magnetic fields offer maneuverability, precision and stability that are often not possible with traditional catheters; that is the company's own description.

"FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology," said David Fischel, the company's chairman and chief executive, in the release.

Conditions of approval

The FDA's approval order, dated January 5, requires Stereotaxis to run the MAGiC-CHD post-approval study, a prospective, non-randomized, single-arm study in which at least 40 adult patients with congenital heart disease will undergo ablation with the catheter. Atrial fibrillation is excluded. Patients will be enrolled in the US, the European Union or Canada, with most in the US, and followed for six months.

The study's primary objectives are to estimate rates of acute procedural success, chronic success through six months and device- or procedure-related serious adverse events through seven days. The order requires the first patient to be enrolled within six months of protocol approval and full enrollment within 24 months. It also sets the device's expiration dating at 18 months.

Launch plans

Fischel told MassDevice the company plans to launch the product in early 2026, as reported by Medical Tubing and Extrusion, a sister publication. In that interview he called it "the first ablation catheter ever approved specifically for this indication," a company claim. The publication reported that the device received a CE mark in Europe in January 2025.

MAGiC shares its name with Stereotaxis' MAGiC Sweep mapping catheter, a separate product that the publication said received 510(k) clearance in July 2025. The publication also reported that Stereotaxis is working with CardioFocus on ways to combine that company's pulsed-field ablation technology with the MAGiC catheter.