Stereotaxis surgical robot gets regulatory nod in China

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The Stereotaxis Genesis RMN, which features two large, white robotic arms with magnets on each end, sitting in between the arms is a table.

The Genesis RMN System features flexible robotic arms holding Genesis magnets for increased system angulation and associated imaging angulation. | Source: Stereotaxis

Stereotaxis Inc. this week announced that its Genesis surgical robot has received regulatory approval in China. The company said the system delivers safe and precise cardiac ablation to treat arrhythmias.

Genesis uses small magnets that rotate along their center of mass, allowing for responsiveness to physician control. Flexible, rugged robotic arms hold the agents to increase the potential range of motion and allow for wider X-ray angulation, according to Stereotaxis.

Founded in 1990, Stereotaxis has developed surgical robots for minimally invasive endovascular intervention. The St. Louis, Mo.-based company said its systems can expand access to minimally invasive therapy and enhance the productivity, connectivity, and intelligence in the operating room.

China market

China’s National Medical Products Administration (NMPA) granted the approval to Stereotaxis and Shanghai MicroPort EP Medtech Co. for the Genesis robotic magnetic navigation (RMN) system. Stereotaxis said it marks a “significant milestone” as it expands access to minimally invasive robotic technology in China.

In 2021, the company inked a collaboration with MicroPort EP for distribution and commercialization in China.

“We are delighted to receive NMPA clearance for the Genesis System in China,” stated David Fischel, Stereotaxis chair 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.”

MicroPort EP plans to begin a full launch of Genesis through existing sales teams. The companies said the approval is a key element of their broader collaboration. That includes development, integration, and commercialization of Stereotaxis’ robotic system, robotically navigated catheters, and the MicroPort EP Columbus 3D mapping system.

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Stereotaxis marks recent milestones

Earlier this month, Stereotaxis announced that physicians at the University of Kansas Health System successfully treated its first patients with its Genesis system. The smaller RMN system can improve the patient experience, provide greater patient access, and increase lab space, said the company.

In August, Stereotaxis submitted its next-generation GenesisX system to the U.S. Food and Drug Administration (FDA) following its receipt of the CE mark in Europe. The company said its technology has been used to treat more than 150,000 patients around the world, including in Portugal and Italy.

In addition, a hospital in Kentucky performed the first procedures with the Genesis surgical robot late last year. Stereotaxis also has an ongoing collaboration with Abbott, which had milestone developments last fall.

Editor’s Note: This article was syndicated from The Robot Report sibling site MassDevice. Stereotaxis featured on its 2024 list of 10 surgical robotics companies to follow in 2024.