Stereotaxis’ GenesisX Robotic Magnetic Navigation System Obtains CE Mark

August 12, 2024—Stereotaxis announced it has obtained CE Mark approval in Europe for GenesisX, a next-generation robotic magnetic navigation (RMN) system for endovascular interventions. The company also advised it has submitted a 510(k) application to the FDA for market clearance in the United States.

According to the company, GenesisX maintains the speed, responsiveness, and efficient workflow of the company’s Genesis system and is smaller and lighter than previous generation RMN systems.

Additionally, Stereotaxis stated that GenesisX has features that reduce the complexities and barriers to hospital adoption of the technology. It utilizes smaller magnets and incorporates magnetic shielding into its structure instead of the shielding otherwise installed in the walls of the operating room, and it requires no structural anchoring through the floor 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, the company notes.

In the coming months, Stereotaxis plans 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, said the company.