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Stereotaxis Achieves CE Mark in Europe and Submits 510(k) in the US for Next Generation Robotic System GenesisX
Stereotaxis (NYSE: STXS), a leader in surgical robotics for minimally invasive endovascular intervention, has achieved significant milestones for its next-generation robotic system, GenesisX. The company has obtained CE mark in Europe and submitted a 510(k) application to the FDA in the US. GenesisX builds upon the established benefits of Robotic Magnetic Navigation (RMN) systems while reducing adoption barriers for hospitals.
Key improvements include smaller magnets, integrated magnetic shielding, no need for structural anchoring, standard power requirements, and an 80% smaller system cabinet. These advancements significantly reduce installation complexities and costs. Stereotaxis plans to launch GenesisX in 2025, focusing on regulatory approvals for compatible catheters, real-world demonstrations, and preparing supply chain and commercial processes
Key improvements include smaller magnets, integrated magnetic shielding, no need for structural anchoring, standard power requirements, and an 80% smaller system cabinet. These advancements significantly reduce installation complexities and costs. Stereotaxis plans to launch GenesisX in 2025, focusing on regulatory approvals for compatible catheters, real-world demonstrations, and preparing supply chain and commercial processes
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