Stereotaxis receives FDA clearance for GenesisX robotic system

ST. LOUIS - Stereotaxis (NYSE:STXS) announced Monday it has received U.S. Food and Drug Administration 510(k) clearance for its GenesisX robotic system for minimally invasive endovascular intervention.

The new system features a compact design with integrated magnetic shielding, eliminating the need for specialized room modifications. It operates on standard power outlets, requires no structural anchoring, and has an 80% smaller system cabinet compared to previous models, allowing installation in existing catheterization laboratories without complex construction.

"This is a landmark approval as we transform the accessibility and scalability of Robotic Magnetic Navigation," said David Fischel, Chairman and CEO of Stereotaxis, in the press release.

Dr. Francis Marchlinski, Director of Electrophysiology at the University of Pennsylvania Health System, noted that the system's simplified installation requirements help "bring the precision of robotic navigation and its ease of use for the operator to a broader patient population."

The company has begun a limited launch of GenesisX in the United States and Europe while expanding its portfolio of compatible catheters and enhancing various operational processes before a full launch. The system offers flexible financing options including sales, leases, and pay-per-use models.

Stereotaxis specializes in surgical robotics for minimally invasive endovascular procedures. According to the company, its technology has been used to treat over 150,000 patients globally.

In other recent news, Stereotaxis announced it has received CE Mark approval in Europe for its Synchrony system and has submitted a 510(k) application to the U.S. Food and Drug Administration. The Synchrony system is designed to modernize catheterization labs with a 55-inch 4K ultra-high-definition display that consolidates viewing and control, offering custom layouts and streamlined workflows. In addition, Stereotaxis has partnered with CardioFocus to develop and commercialize robotic Pulsed Field Ablation (PFA) technology, aimed at treating cardiac arrhythmias. This collaboration merges Stereotaxis' robotic magnetic navigation systems with CardioFocus' Centauri PFA System, which already holds CE marking and has been used to treat over 9,000 patients in Europe. Furthermore, Erasmus University Medical Center in Rotterdam has successfully completed the first procedures in the Netherlands using Stereotaxis' Genesis Robotic Magnetic Navigation System. The Genesis system is the latest advancement in robotic magnetic navigation technology for cardiac ablation procedures. These recent developments highlight Stereotaxis' ongoing efforts in advancing medical technology and expanding its reach in Europe.

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