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Home » Stereotaxis wins CE mark for next-gen surgical robot, submits to FDA

Stereotaxis wins CE mark for next-gen surgical robot, submits to FDA

August 14, 2024 By Sean Whooley

Stereotaxis GensisX robotic magnetic navigation surgical robot system
The GenesisX surgical robot system. [Image courtesy of Stereotaxis]
Stereotaxis (NYSE:STXS) announced that it obtained CE mark in Europe and submitted an FDA 510(k) application for its next-generation surgical robot.

The GenesisX system is the latest iteration of Stereotaxis’ Genesis robotic magnetic navigation (RMN) system. It builds upon the company’s technology while reducing the complexities and barriers to hospital adoption.

Stereotaxis said in a news release that RMN systems require significant preparations within an operating room. That includes structural modifications, installing thousands of pounds of magnetic shielding, floor reinforcement, high electrical power and extensive cabling.

To address this, GenesisX utilizes smaller magnets and incorporates magnetic shielding into its structure. It requires no structural anchoring through the floor and uses standard 120/230V power outlets. A single fiber connects each robot to the system cabinet, which is 80% smaller than the previous generation of Genesis. The system can fit under a table in an operating room and maintains the speed, responsiveness and workflow of Genesis. The company plans to use it as a platform for additional innovations in the future.

With CE mark obtained and a submission made to the FDA, Stereotaxis plans to use the coming months to achieve further milestones. Those include regulatory approval for compatible catheters, real-world data for the system, enhanced capabilities with X-ray systems and supply chain preparation.

Stereotaxis hopes for a full launch and significant adoption in 2025.

“We are excited to introduce GenesisX and share the achievement of these significant milestones,” said David Fischel, chair and CEO. “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.”

Filed Under: 510(k), Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Robotic-Assisted, Surgical, Surgical Robotics Tagged With: Stereotaxis

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About Sean Whooley

Sean Whooley is a senior editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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