Stereotaxis, a pioneer and global leader in surgical robotics for minimally invasive endovascular intervention, today announced it obtained CE mark in Europe and submitted a 510(k) application to the FDA in the US for a next generation robotic system, GenesisX.

“We are excited to introduce GenesisX and share the achievement of these significant milestones,” said David Fischel, Chairman and CEO. “Medical innovation only realizes its full potential to advance and improve patient care if it is designed to be broadly accessible. The clinical value of Stereotaxis’ robotic technology has been extensively demonstrated yet difficult to access for the vast majority of interested physicians and hospitals. GenesisX is strategically transformative as it supports broad adoption of robotics in electrophysiology and across endovascular interventions.”

GenesisX builds upon the established benefits and performance of Robotic Magnetic Navigation (RMN) systems, while reducing the complexities and barriers to hospital adoption of the technology. Preparing an operating room to accommodate a RMN system has typically required significant structural modification, including the installation of thousands of pounds of magnetic shielding in the walls, reinforcement of the floor, high electrical power, and extensive cabling through conduits between the operating room and a dedicated cabinet room. This entailed months of planning and coordination between site planners, architects, and contractors. GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure in place of the shielding otherwise installed in the walls of the operating room. It requires no structural anchoring through the floor and operates using standard 120/230V power outlets. A single fiber is routed from each robot to the system cabinet, which is 80% smaller than the cabinet of Genesis and can fit under a table in the operating room. GenesisX is smaller and lighter than any previous generation system, and maintains the speed, responsiveness, and efficient workflow of Genesis. GenesisX will serve as a platform for additional innovations in the future.

GenesisX has obtained CE mark in Europe and has been submitted to the FDA for 510(k) clearance in the United States. Stereotaxis plans to use the coming months to gain regulatory approval for compatible catheters, demonstrate real-world use of the system, enhance compatibility with various x-rays, and prepare supply chain, manufacturing, installation and commercial processes for a full launch and significant adoption of GenesisX in 2025.