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Stereotaxis’ Genesis Surgical Robot OK’ed in China

Stereotaxis' Genesis surgical robot is touted as the latest in robotic magnetic navigation technology.

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By: Sam Brusco

Associate Editor

Stereotaxis and Shanghai MicroPort EP Medtech announced regulatory approval of the Genesis RMN (robotic magnetic navigation) system by China’s National Medical Products Administration (NMPA).

MicroPort EP is beginning full commercial launch of the Genesis surgical robot through existing sales teams that are focused on the electrophysiology community.

Genesis’ approval is a crucial element in a broader partnership between Stereotaxis and MicroPort EP which encompasses development, integration, and commercialization of Stereotaxis’ robotic system, robotically-navigated catheters, and MicroPort EP’s Columbus 3D mapping system.

MicroPort EP is A Chinese device company with a portfolio of cardiovascular devices to diagnose and treat arrythmias. The duo announced their collaboration in August 2021.

“We are proud to partner with Stereotaxis to bring the benefits of the Genesis system to China,” said Dr. Yiyong Sun, President of MicroPort EP. “We look forward to launching this significant technology and continuing our partnership to provide China’s electrophysiology community with the most advanced innovations.”

Genesis is touted as the latest in robotic magnetic navigation technology. Robotic magnetic navigation adds robotic precision and safety to minimally invasive endovascular procedures, according to Stereotaxis.

Genesis RMS is U.S. Food and Drug Administration (FD) cleared and CE marked.

“We are delighted to receive NMPA clearance for the Genesis System in China,” said David Fischel, Stereotaxis chairman and CEO. “This approval represents another key milestone as we establish the foundations for significant growth across key focus geographies. Our investment to advance the substantial innovations underscores our commitment to pioneering the frontiers of medical technology to improve the lives of patients with cardiovascular disease around the world.”

Earlier this year, Stereotaxis began a deal to acquire Access Point Technologies, which has a portfolio of diagnostic catheters used in cardiac ablation procedures.

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