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.
Stereotaxis claims that MAGiC Sweep is the first FDA-cleared robotically navigated EP mapping catheter for diagnosing heart arrhythmia.
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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’s electrical pathways, MAGiC Sweep is designed to diagnose which abnormal circuits or regions are causing arrhythmia.
With a diagnosis made, using radiofrequency energy, Stereotaxis’ MAGiC ablation catheter, which received a European CE marking in January 2025, can destroy the areas of heart tissue responsible for causing a patient’s 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.
