GenesisX marks the latest advancement in endovascular surgical robotics, the St. Louis-based company says. It builds on the company’s established robotic magnetic navigation (RMN) technology while enhancing its accessibility.
Clearance for the endovascular surgical robot comes just days after Microbot Medical launched its own endovascular robot, which won FDA clearance in September. Other potential entrants into the endovascular robot space with recent milestones include Remedy Robotics and Sentante.
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The latest-generation Stereotaxis system includes a compact, efficient design that incorporates magnetic shielding into its structure. This shielding would otherwise be installed in the walls of the operating room. The system operates on standard 120/230V power, requires no structural anchoring and has an 80% smaller system cabinet.
Stereotaxis said these features enable installation in existing, non-modified cath labs without complex architectural planning or construction. GenesisX’s smaller, lighter design enhances workflow efficiency while maintaining high standards in speed and responsiveness. The system can fit under a table in an operating room and could serve as a platform for additional innovations in the future.
GenesisX won CE mark in August 2024, at which point the company said it submitted the robot to the FDA. Stereotaxis reported the first order for the system at the beginning of this year.
Now, the company says it kicked off a limited launch for GensisX in the U.S. and Europe. Simultaneously, it’s expanding its portfolio of compatible catheters to enhance compatibility with various x-rays, demonstrating commercial use and enhancing supply chain, manufacturing, installation and commercial processes ahead of a full launch. The company says its flexibility as a capital system enables alternative financing models like sales, leases and pay-per-use.
“This is a landmark approval as we transform the accessibility and scalability of robotic magnetic navigation, pioneering broad robotic adoption across endovascular surgery,” said David Fischel, chair and CEO of Stereotaxis. “We thank and congratulate all those who helped us reach this milestone. Successful development, approval, and deployment of complex surgical robots that operate reliably in daily clinical use is a unique expertise. This is our second robotic system launched within five years, reflecting our commitment and capacity to drive significant innovation in electrophysiology and endovascular medicine.”
