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Stereotaxis Receives U.S. FDA Clearance for MAGiC Sweep Catheter
Globenewswire· 2025-07-28 11:48
Core Insights - Stereotaxis has received FDA 510(k) clearance for its MAGiC Sweep™ catheter, marking a significant advancement in electrophysiology mapping technology [1][2][3] - The MAGiC Sweep is the first robotically navigated high-density electrophysiology mapping catheter, enhancing the diagnosis and treatment of complex arrhythmias [1][2] Company Overview - Stereotaxis is a pioneer in surgical robotics for minimally invasive endovascular interventions, focusing on the development of robotic systems and instruments to improve patient care [3] - The company has treated over 150,000 patients globally, showcasing its commitment to advancing robotic technology in healthcare [3] Product Features - The MAGiC Sweep catheter is equipped with 20 electrodes for rapid and detailed electroanatomical mapping of heart chambers [4] - It integrates seamlessly with Stereotaxis' robotic systems, allowing precise navigation to challenging areas of the heart [4] - The catheter's atraumatic design prioritizes patient safety and supports anatomically accurate mapping by minimizing distortion [4] - It enhances workflow efficiency in robotic procedures, particularly with the development of automated mapping algorithms [4] Industry Impact - The introduction of the MAGiC Sweep catheter is expected to significantly improve cardiac ablation procedures by providing more efficient and detailed mapping of arrhythmias [2] - Experts in the field view this development as a major milestone that will positively impact patient outcomes and expand the capabilities of robotic electrophysiology [2]