Joint venture Sino-European MicroRobotics (Shanghai) Co. Ltd. (SEMR) has gained China National Medical Products Administration (NMPA) approval for its spinal surgical navigation and positioning system. The authorization follows the technology’s fast-track entry into the NMPA’s Innovative Medical Device Expedited Review Pathway (the “Green Channel”) in February 2024.

Leveraging Micromate robotic technology, the device’s approval was partly driven by a successful international collaboration between Austria-based company Interventional Systems and Chinese company HICREN. The product is the first miniature orthopedic surgical robot to be accepted into the NMPA’s Green Channel program.

“[This approval] marks its official entry into clinical application. It represents a significant milestone in China’s advancement toward minimally invasive orthopedic robotics. It is particularly noteworthy that the core navigation and positioning technology of this product deeply integrates the achievements of our close collaboration with Interventional Systems (INS),” HICREN and SEMR Chairman/General Manager M.A. Yan stated. “Through the sharing of cutting-edge technology and joint R&D, we have successfully achieved the seamless integration of INS’s advanced navigation algorithms with the Intelligent SpinePecker Miniature Spinal Surgical Robot’s miniaturized and intelligent platform. This accomplishment transcends mere technical cooperation; it stands as a model of international commercial collaboration, laying a solid foundation for the product’s exceptional performance and its future expansion.” 

Commercially known as the Intelligent SpinePecker, the system is designed to meet the demands of modern surgery. Reportedly one of the world’s smallest orthopedic surgical robots, its palm-sized robotic arm weighs 1.63 kg (3.6 pounds), and the entire system is integrated into a mobile console occupying a 0.32 m² footprint. In addition, setup takes less than 10 minutes.

It also delivers ultra-high precision with a 0.2 mm positioning accuracy, and its workflow reduces surgical time, allowing for single pedicle screw placement in just one minute, according to the companies. Its intelligent algorithms simplify surgical planning, enabling a shorter learning curve, and creating a scalable platform for future innovation.

“Interventional Systems is excited about the cooperation and partnership with HICREN/SEMR. Through cooperation, our teams have been able to conceptualize, develop, clinically validate, and launch a minimally invasive robotic navigation system based on the Micromate technology that has the patient as a priority,” Interventional Systems Founder/Managing Director Dr. Michael Vogele said. “We have decided since the beginning to follow a percutaneous approach with minimally invasive nature, leveraging the interventional roots of both companies. Developing a product with micro-invasiveness as a cornerstone is better for patients and healthcare systems. We are proud to have a strategic partner that shares our core values, and excited to see already substantial traction and demand in China for the technology”. 

The Intelligent SpinePecker Miniature Spinal Surgical Robot will be launched this month.  

Based in Kitzbühel, Austria, Interventional Systems (iSYS Medizintechnik GmbH) is a pioneer in miniature robotics for image-guided medical procedures, renowned for its core Micromate robotic platform. HICREN (Ningbo HicRen Biotechnology Co., Ltd.) is a Chinese medical technology company developing orthopedic and spinal surgery solutions. The two companies partnered to create the joint venture Sino-European MicroRobotics (Shanghai) Co. Ltd. (SEMR), which is focused on researching developing, and commercializing advanced surgical robotics in China.