Stereotaxis announced on July 28, 2025, that it received U.S. Food and Drug Administration (FDA) 510(k) clearance for its MAGiC Sweep™ catheter. This marks a significant advancement as the world’s first robotically navigated high-density electrophysiology (EP) mapping catheter, designed to diagnose and treat complex arrhythmia patients.
High-density mapping has revolutionized the EP field by enabling more efficient, detailed, and precise identification of arrhythmia origins during cardiac ablation procedures. The combination of high-density mapping with robotics is expected to offer multiple improvements, including enhanced mapping accuracy and the ability to reach difficult areas of the heart.
This FDA clearance is a pivotal moment for Stereotaxis, representing its first FDA clearance for an interventional catheter in nearly 20 years. It underscores the company's commitment to advancing a broad portfolio of differentiated robotically-navigated catheters and is a key component of its comprehensive innovation strategy across endovascular interventions.
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