Stereotaxis Gets Key EU Clearance to Market GenesisX Robotic System

By Stephen Nakrosis

Stereotaxis said its GenesisX robotic system obtained a CE mark in Europe, a designation signifying a product has been assessed to meet safety, health and environmental requirements in the European Union.

Stereotaxis on Monday said the system is a smaller, easier-to-use Robotic Magnetic Navigation system, which is used to guide catheters through the chambers of the human heart during certain procedures. The company said its new system eliminated the need for the structural modifications to operating rooms required by an earlier system, which could include installing thousands of pounds of magnetic shielding in the walls, reinforcing floors and other changes.

The St. Louis company also said the GenesisX had been submitted to the U.S. Food and Drug Administration for 510(K) clearance in the U.S. This is a premarket submission made to demonstrate a device which will be marketed is as safe and effective as a device which has already been legally marketed.

The company said it plans to use the coming months to gain regulatory approval for compatible catheters, demonstrate real-world use of the system, and prepare for a full launch of GenesisX next year.

Write to Stephen Nakrosis at stephen.nakrosis@wsj.com

(END) Dow Jones Newswires

August 12, 2024 18:03 ET (22:03 GMT)

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