ST. LOUIS, Jan. 06, 2026 (GLOBE NEWSWIRE) -- Stereotaxis (NYSE: STXS), a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained U.S. Food and Drug Administration (FDA) approval for the MAGiC™ Magnetic Interventional Ablation Catheter. “FDA approval of MAGiC is a significant milestone for Stereotaxis and the community of physicians pioneering robotics in electrophysiology. It ensures the benefits of Robotic Magnetic Navigation can support ...

Core Insights - Stereotaxis has received FDA 510(k) clearance for its new robotic system, GenesisX, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][3] Product Features - GenesisX enhances Robotic Magnetic Navigation technology, featuring a compact design with magnetic shielding integrated into its structure, allowing for installation in existing cath labs without extensive modifications [2] - The system operates on standard 120/230V power, requires no structural anchoring, and has an 80% smaller system cabinet, improving workflow efficiency while maintaining high standards of speed and responsiveness [2] Market Impact - The approval of GenesisX is expected to broaden the adoption of robotic technology in endovascular surgery, addressing previous infrastructure challenges that limited its use among physicians [3] - Stereotaxis has initiated a limited launch of GenesisX in the U.S. and Europe, while expanding its portfolio of compatible catheters and enhancing various operational processes for a full launch [3] Company Overview - Stereotaxis is a leader in surgical robotics, focusing on the development of innovative systems for minimally invasive interventions, with a mission to improve patient care and operational efficiency in interventional laboratories [4] - The company's technology has been utilized to treat over 150,000 patients globally, demonstrating its impact and reach in the healthcare sector [4]

Core Insights - Stereotaxis has successfully launched its Genesis Robotic Magnetic Navigation System at Erasmus University Medical Center in Rotterdam, marking a significant advancement in surgical robotics for minimally invasive endovascular interventions [1][2]. Company Overview - Stereotaxis is a pioneer in surgical robotics, focusing on minimally invasive endovascular interventions, with a mission to develop robotic systems and solutions that enhance patient care and operational efficiency in interventional laboratories [3]. Technological Advancements - The Genesis System represents the latest in Robotic Magnetic Navigation technology, which enhances precision and safety in cardiac ablation procedures for treating arrhythmias [2]. - The combination of the Genesis system and the MAGiC Catheter has shown synergistic improvements in robotic magnetic navigation, which is crucial for providing optimal care to arrhythmia patients, including those with complex conditions [2]. Clinical Impact - Erasmus MC has performed over 4,500 procedures using Stereotaxis technology, demonstrating the effectiveness and reliability of robotic magnetic navigation in complex arrhythmia treatments [2]. - Arrhythmias affect tens of millions globally, and untreated cases can lead to severe health risks such as stroke and heart failure, highlighting the importance of advanced treatment options like those offered by Stereotaxis [2].