Stereotaxis Submits First Ever Robotically Navigated High-Density EP Mapping Catheter for Regulatory Clearance

Core Insights - Stereotaxis has announced the FDA regulatory submission for the MAGiC Sweep™ catheter, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][3] - The MAGiC Sweep is the first high-density electrophysiology (EP) mapping catheter designed for robotic navigation, which is expected to enhance cardiac ablation procedures through improved mapping capabilities [2][3] Company Developments - The MAGiC Sweep catheter allows for rapid and detailed electroanatomical mapping from 20 electrodes, improving safety and accuracy in mapping difficult areas of the heart [2][3] - Stereotaxis plans to submit the MAGiC Sweep for European CE Mark clearance and anticipates a broad commercial launch in the second half of the year following expected regulatory approvals [3][4] - The company has also introduced the EMAGIN 5F vascular guidance catheter, indicating a strategic expansion of its product portfolio [4] Industry Impact - The introduction of the MAGiC Sweep catheter is seen as a major milestone in the EP field, potentially transforming the approach to arrhythmia treatment by enabling high-resolution mapping [3] - Stereotaxis aims to solidify its position as a leader in robotic technology with a diverse range of proprietary catheters, reflecting its commitment to innovation in surgical robotics [4]