Stereotaxis, Inc. (STXS) announced that it performed the first U.S. procedures with its newly FDA‑approved MAGiC magnetic‑navigation ablation catheter on April 22 2026. The device received U.S. Food and Drug Administration pre‑market approval on January 6 2026, and the first commercial use was carried out by Dr. Nathan McConkey at Oregon Health & Science University.
The procedures targeted atrial flutter in a patient with complex congenital heart disease whose anatomy made manual catheter ablation ineffective. Dr. McConkey reported that the MAGiC catheter, steered by Stereotaxis’s robotic magnetic navigation system, delivered precise, stable contact force and energy delivery, allowing the ablation to be completed without recurrence in the weeks that followed.
This milestone marks the first commercial deployment of MAGiC in the United States and represents a significant expansion of Stereotaxis’s product portfolio into a high‑margin, high‑complexity market segment. The launch is a key step in the company’s strategy to transition from a capital‑equipment vendor to a recurring‑revenue razor‑and‑blade platform, potentially unlocking new revenue streams and improving overall profitability.
Stereotaxis’s 2025 full‑year results provide context for the significance of the launch. Revenue rose 20% to $32.4 million, with recurring revenue growing 21% to $22.2 million and system revenue up 18% to $10.2 million. Gross margins were approximately 53%, with recurring revenue margins at 67% and system margins at 21%. The company guided for 2026 revenue above $40 million and is working toward profitability, citing reduced cash use and a focus on recurring revenue.
Manufacturing capacity for the MAGiC catheter has been a focus of the company’s recent efforts. In late 2025 and early 2026, Stereotaxis faced production bottlenecks at its contract manufacturer, Osypka, but expects to scale output to roughly 500 catheters per month by the end of 2026. In addition, the company announced a definitive agreement to acquire Robocath on April 15 2026, further expanding its endovascular robotics capabilities.
Management has highlighted the clinical and commercial impact of the launch. Dr. McConkey noted that “MAGiC is an outstanding tool for reaching challenging substrate in patients with complicated anatomy. The stability, contact force, and energy delivery are all a substantial improvement over older magnetic catheters, and many ablations in my complex congenital patients would be impossible without this new technology.” CEO David Fischel emphasized that the FDA approval “represents a major advance in robotic cardiac ablation technology and provides a foundation for continued technological and clinical progress.”
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