FDA clears new-look robotic system from Stereotaxis
Stereotaxis, a St. Louis-based medtech company, has received U.S. Food and Drug Administration (FDA) clearance for its GenesisX endovascular robotic system.
According to Stereotaxis, GenesisX represents the company’s most accessible robotic system to date. The technology was specifically designed to be compact, efficient and easy to install. It requires no room shielding or structural anchoring, for example, and the size has been reduced enough that it should fit into any standard cath lab.
While system components have been adjusted to make these different changes possible, GenesisX still offers users the company’s robotic magnetic navigation technology for guiding catheters exactly where they need to go.
“For years, challenging infrastructure demands limited the adoption of robotic technology amongst the community of physicians interested in its clinical benefits,” Francis Marchlinski, MD, professor of medicine and director of electrophysiology at the University of Pennsylvania Health System, said in a statement. “The GenesisX design changes that by dramatically simplifying installation. This helps to more readily bring the precision of robotic navigation and its ease of use for the operator to a broader patient population.”
“This is a landmark approval as we transform the accessibility and scalability of robotic magnetic navigation, pioneering broad robotic adoption across endovascular surgery,” added David Fischel, chairman 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.”
The GenesisX system gained CE mark approval in August 2024. Stereotaxis has officially launched the GenesisX in certain U.S. and European markets. Throughout the development process, the company has been working to expand its portfolio of catheters that are compatible with the new system.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.