Stereotaxis Gets EU Nod for GenesisX Robot, Submits 510(k) App

Stereotaxis has earned CE mark clearance for its next-generation robotic system, GenesisX. The company also submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for the technology.
 
The company said GenesisX builds on the established benefits and performance of robotic magnetic navigation (RMN) systems, while reducing complexities and barriers to hospitals adopting the technology.
 
Preparing an operating room to accommodate a RMN system has typically required significant structural modification, including 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 OR and a dedicated cabinet room. This required months of planning and coordination between site planners, architects, and contractors.
 
GenesisX, according to Stereotaxis, uses smaller magnets and incorporates magnetic shielding in its structure, instead of shielding installed in the OR walls. To doesn’t need structural anchoring through the floor and is powered by standard 120/320V power outlets.
 
One fiber is routed from each robot to the system cabinet, which is 80% smaller than the previous-gen Genesis cabinet and can fit under a table in the OR. The company said GenesisX will be a platform for further, future innovations.
 
Stereotaxis plans to achieve regulatory approval for compatible catheters, show the system’s real-world use, enhance its compatibility with various X-rays. The company will also prepare supply chain, manufacturing, installation, and commercial processes for full launch in 2025.
 
“We are excited to introduce GenesisX and share the achievement of these significant milestones,” said David Fischel, Stereotaxis’ 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.”
 
The company began a deal to acquire Access Point Technologies (APT), a privately-held developer of electrophysiology catheters, in May.