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GenesisX Robotic Magnetic Navigation System Receives U.S. FDA Clearance
Globenewswire· 2025-11-10 21:05
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]