Stereotaxis Genesis Robotic System Achieves Regulatory Approval in China

STXS
October 05, 2025

Stereotaxis and Shanghai MicroPort EP Medtech Co., Ltd. announced on November 25, 2024, that China’s National Medical Products Administration (NMPA) has granted regulatory approval for the Genesis RMN System. This approval is a significant milestone, making the latest advancements in minimally-invasive robotic technology available to physicians and patients across China.

MicroPort EP is set to initiate the full commercial launch of the Genesis system through its existing sales teams, which are focused on the electrophysiology community. This approval is a key component of a broader collaboration between Stereotaxis and MicroPort EP, established in August 2021, which includes the development, integration, and commercialization of robotic systems and catheters.

The Genesis RMN System, which already holds FDA clearance and CE Mark in the U.S. and Europe, introduces robotic precision and safety to endovascular procedures. This NMPA clearance establishes a foundation for Stereotaxis to achieve significant growth in a key geographical market, underscoring its commitment to pioneering medical technology globally.

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