Stereotaxis, a pioneer in surgical robotics for minimally invasive endovascular intervention, has earned U.S. Food and Drug Administration (FDA) 510(k) clearance for its GenesisX lastest-generation robotic system.

GenesisX was built on the benefits of robotic magnetic navigation while boosting the technology’s accessibility, the company said. It features a compact and efficient design, incorporating magnetic shielding into its structure in place of shielding otherwise installed in operating room walls.

It operates on standard 120/230V power, doesn’t need structural anchoring, and has an 80% smaller system cabinet. GenesisX can be installed in existing non-modified cath labs without complex architectural planning or construction, the company said.

“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, 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.”

Dr. Francis Marchlinski, Professor of Medicine and Director of Electrophysiology at the University of Pennsylvania Health System said for years, challenging infrastructure demands limited robotic technology adoption among the physician community interested in its clinical benefits.

“The GenesisX design changes that by dramatically simplifying installation,” Dr. Marchlinski told the press. “This helps to more readily bring the precision of robotic navigation and its ease of use for the operator to a broader patient population.”

Stereotaxis began a limited launch of GenesisX in the U.S. and Europe while expanding its portfolio of compatible catheters, enhancing compatibility with various X-rays, demonstrating commercial use, and enhancing supply chain, manufacturing, installation and commercial processes for a full launch.

Last month, the company gained CE mark approval and submitted a 510(k) application to the FDA for its Synchrony system.