Stereotaxis has received US Food and Drug Administration (FDA) clearance for MAGiC Sweep, an electrophysiology (EP) catheter.
Shares in the company rose by 10.66% from $2.25 at market close on 25 July to $2.49 at market open on 28 July, following the announcement.
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Stereotaxis claims that MAGiC Sweep is the first FDA-cleared robotically navigated EP mapping catheter for diagnosing heart arrhythmia.
The catheter is equipped with 20 electrodes for the electroanatomical mapping of the heart chambers. According to Stereotaxis, the catheter provides more anatomically accurate maps since it avoids the distension associated with rigid catheters.
By providing 3D maps of the heart鈥檚 electrical pathways, MAGiC Sweep is designed to diagnose which abnormal circuits or regions are causing arrhythmia.
With a diagnosis made, using radiofrequency energy, Stereotaxis鈥� MAGiC ablation catheter, which received a European CE marking in January 2025, can destroy the areas of heart tissue responsible for causing a patient鈥檚 arrhythmia. The company submitted a premarket application for MAGiC to the FDA in 2024 and expects to receive clearance in the US later this year.
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By GlobalDataStereotaxis chairman and CEO, David Fischel, commented: “MAGiC Sweep is Stereotaxis鈥� first FDA clearance for an interventional catheter in nearly 20 years, but is only the first of multiple robotically steered interventional devices being advanced as part of our comprehensive innovation strategy.鈥�
Stereotaxis鈥� catheters are designed for use with the company鈥檚 Genesis robotic magnetic navigation (RMN) and GenesisX robotic systems. Genesis RMN received FDA clearance in 2020 while GenesisX secured EU clearance in 2024, with FDA clearance expected later this year.
According to GlobalData analysis, robotic surgical systems and their accessories are projected to reach a global valuation of $15.8bn by 2030, up from $10bn in 2024.
Ablation has become a mainstay in treating heart arrhythmias such as atrial fibrillation (AFib). However, following the US approval of Medtronic鈥檚 PulseSelect in late 2023 and Boston Scientific鈥檚 Farapulse pulsed field ablation (PFA) system in early 2024, uptake has been swift, with PFA appearing likely to become the dominant treatment modality moving forward.
Boston Scientific鈥檚 recent Q2 2025 financials revealed a 26.8% profit rise in its cardiovascular unit to $3.34bn versus $2.63bn in Q2 2024, an uplift due in large part to sales of Farapulse PFA.
