China’s National Medical Products Administration granted approval for the Genesis robotic magnetic navigation (RNM) system.
Genesis delivers the benefits of robotic precision and safety to cardiac ablation to treat arrhythmias. The system utilizes smaller 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.
Stereotaxis said the approval marks a significant milestone as it expands access to the minimally invasive robotic technology in China. In 2021, the company inked a collaboration with MicroPort EP, a Shanghai-based firm, for distribution and commercialization in China.
MicroPort EP plans to begin a full launch of Genesis through existing sales teams. This approval represents a key element of the companies’ broader collaboration, which entails the development, integration and commercialization of Stereotaxis’ robotic system, robotically navigated catheters and the MicroPort EP Columbus 3D mapping system.
“We are delighted to receive NMPA clearance for the Genesis System in China,” said 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.”
Stereotaxis also has an ongoing surgical robotics collaboration with Abbott, which had milestone developments last fall. The company features on MassDevice’s 2024 list of 10 surgical robotics companies you need to know.
