Stereotaxis Inc. immediately introduced that it has secured the primary order for its latest-generation robotic system, GenesisX. The surgical robotic developer stated the system is geared in the direction of minimally invasive endovascular intervention.
“We’re thrilled to announce the primary agency order for GenesisX from a pioneering European hospital,” stated David Fischel, chairman and CEO of Stereotaxis. “Establishing the primary GenesisX robotic lab is a important milestone for us as we advance in the direction of full business launch.”
“We look ahead to demonstrating the efficiency and reliability of GenesisX within the demanding scientific atmosphere,” he added. “GenesisX guarantees to rework the accessibility of robotic magnetic navigation and is central to our mission of driving broad robotic adoption all through endovascular surgical procedure.”
GenesisX advances magnetic navigation
GenesisX builds on the advantages of robotic magnetic navigation (RMN) whereas making the expertise extra accessible for healthcare suppliers, in response to Stereotaxis. The system does this with two enhancements. First, it makes use of smaller magnets, stated the St. Louis, Mo.-based firm.
Second, it incorporates magnetic shielding into its construction instead of the shielding in any other case put in within the partitions of the working room.
These options imply the system requires no structural anchoring via the ground and operates utilizing customary 120/230V energy shops, Stereotaxis stated. As an alternative, a single fiber is routed from every robotic to the system cupboard. This cupboard is 80% smaller than earlier cupboards and might match below a desk within the working room.
Stereotaxis famous that GenesisX is smaller and lighter than its previous-generation system. As well as, the corporate claimed that the system maintains its requirements in pace, responsiveness, and environment friendly workflow.
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Stereotaxis marks 2024 progress and 2025 plans
Stereotaxis hit a lot of milestones in 2024, which included:
- In Might, the corporate established the primary robotic coronary heart process program in Italy at Hospital Santa Maria della Pietà in Naples. With this system, docs can deal with sufferers with coronary heart rhythm issues utilizing robotic ablation procedures. The hospital grew to become the primary in Italy to undertake the Stereotaxis Genesis RMN system.
- Later that month, Stereotaxis acquired CE Mark for its units in Europe below the brand new European Medical Gadget Regulation, or EU MDR, framework. The recertification below MDR covers all Stereotaxis units out there in Europe.
- In November, it introduced that physicians on the College of Kansas Well being System efficiently handled the primary sufferers with its Genesis system. The usage of the Genesis system got here as a part of a robotic coronary heart program on the well being system.
- The corporate’s Genesis surgical robotic acquired regulatory approval in China. Stereotaxis stated it marks a “important milestone” because it expands entry to minimally invasive robotic expertise in China.
Throughout 2025, Stereotaxis stated it plans to achieve regulatory approvals in Europe and the U.S. for a portfolio of suitable electrophysiology (EP) and vascular catheters, exhibit real-world use of GenesisX, and improve the compatibility of GenesisX with numerous X-rays. The corporate can even put together provide chain, manufacturing, set up, and business processes for a full launch.