Stereotaxis announced that the U.S. Food and Drug Administration granted approval for its MAGiC Magnetic Interventional Ablation Catheter on January 6 2026, allowing the company to begin commercial sales of the robotically‑navigated device in the United States. The approval removes a key regulatory hurdle and positions the company to broaden its market reach beyond its original electrophysiology focus.
The approval comes at a time when Stereotaxis has been navigating a challenging financial landscape. Full‑year 2023 revenue fell to $26.8 million from $28.1 million in 2022, and fourth‑quarter 2023 revenue was $4.6 million versus $7.3 million in the same quarter a year earlier. Operating losses widened to $11.3 million in 2023, and net losses reached $10.2 million. Gross margin for the year was 56%, with recurring revenue enjoying a 79% margin compared to 8% for system revenue. These figures illustrate the company’s ongoing pressure to convert its robotic platform into a profitable, recurring‑revenue business.
The MAGiC catheter is a critical component of Stereotaxis’ razor‑and‑blades strategy. The robotic system (the razor) generates recurring revenue through the sale of catheters and other disposables (the blades). By adding an FDA‑approved ablation catheter, the company can deepen its penetration into the complex‑arrhythmia market, particularly for patients with congenital heart disease or prior surgical interventions that limit traditional catheter access. The new product also expands the company’s addressable market and provides a new revenue stream that can help offset the high upfront costs of system sales.
CEO David Fischel emphasized that the approval “represents a major advance in robotic cardiac ablation technology and provides a foundation for continued technological and clinical progress.” He noted that revenue growth has been challenged by lost royalties and catheter shortages, but the new catheter offers a path to higher recurring revenue and stronger market positioning. Analysts have maintained a “Strong Buy” consensus, with a price target range of $4.00 to $4.20, reflecting confidence in the company’s ability to monetize its platform once the new catheter is commercialized.
The approval also follows earlier milestones, including a 510(k) clearance for the GenesisX robotic system in November 2025 and a European CE Mark for the MAGiC ablation catheter in January 2025. Together, these regulatory achievements underscore Stereotaxis’ progress toward establishing a comprehensive, globally approved ecosystem of robotic navigation and disposable catheters.
Overall, the FDA clearance of the MAGiC ablation catheter marks a significant step for Stereotaxis, potentially accelerating its transition from a niche technology provider to a mainstream player in the electrophysiology market. The company’s ability to convert this regulatory win into commercial success will be closely watched by investors and industry observers alike.
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