Stereotaxis Receives FDA 510(k) Clearance For MAGiC Sweep Catheter

Author: Benzinga Newsdesk | July 28, 2025 06:49am

Stereotaxis (NYSE:STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its groundbreaking MAGiC Sweep™ catheter. MAGiC Sweep is the world's first robotically navigated high-density electrophysiology (EP) mapping catheter, representing a significant advancement in the technology available to diagnose and treat complex arrhythmia patients.

High density mapping has transformed the EP field, enhancing cardiac ablation procedures by enabling more efficient, detailed and precise identification of arrhythmia origin. The combination of high-density mapping with robotics is designed to offer multiple improvements:

• Efficient High-Density Mapping: Equipped with 20 electrodes, MAGiC Sweep facilitates rapid and detailed electroanatomical mapping of the heart chambers.
• Extended Reach & Precision: Seamless integration with Stereotaxis' Robotic Systems enables precise navigation of the catheter to otherwise difficult to reach areas of the heart.
• Atraumatic Design: The catheter's design prioritizes patient safety with an atraumatic shaft.
• Anatomical Accuracy: The catheter supports more anatomically accurate maps by avoiding the distension caused by rigid catheters.
• Efficient Workflow: MAGiC Sweep enables improved robotic procedural workflow, particularly as Stereotaxis advances algorithms that support automated mapping with MAGiC Sweep.

Posted In: STXS