Leveraging Micromate™ robotic technology, the new device’s approval for clinical use marks a new era for robot-assisted spinal surgery in China, driven by a successful international collaboration between Austria-based company Interventional Systems and Chinese company HICREN.
Joint venture Sino-European MicroRobotics (Shanghai) Co., Ltd. (SEMR) has received Class III Medical Device Registration approval from the China National Medical Products Administration (NMPA) for its spinal surgical navigation and positioning system. This approval follows the technology’s fast-track entry into the NMPA’s Innovative Medical Device Expedited Review Pathway (the “Green Channel”) in February 2024, a distinction that makes it China’s first miniature orthopedic surgical robot to be accepted into the program.
The system, commercially known as the Intelligent SpinePecker, offers a powerful combination of features designed to meet the demands of modern surgery. As one of the world’s smallest orthopedic surgical robots, its palm-sized robotic arm weighs only 1.63 kg, and the whole system is integrated into a mobile console occupying a minimal 0.32 m² footprint, whose setup takes less than 10 minutes.
It also delivers ultra-high precision with a positioning accuracy of 0.2 mm, which is complemented by its efficiency, with a workflow that reduces surgical time, allowing for single pedicle screw placement in just one minute. Its intelligent algorithms simplify surgical planning, enabling a shorter learning curve, and creating a scalable platform for future innovation.
Mr. MA Yan, Chairman and General Manager of HICREN and SEMR, stated,
“[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). 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.”
Dr. Michael Vogele, Founder and Managing Director of Interventional Systems, said,
“Interventional Systems is excited about the cooperation and partnership with HICREN/SEMR. Through outstanding 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. 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 launch of the Intelligent SpinePecker Miniature Spinal Surgical Robot is scheduled for September 2025.
About the companies
Interventional Systems (iSYS Medizintechnik GmbH), based in Kitzbühel, Austria, 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 dedicated to developing innovative solutions for orthopedic and spinal surgery. The two companies partnered to create the joint venture Sino-European MicroRobotics (Shanghai) Co., Ltd. (SEMR), which is focused on the research, development, and commercialization of advanced surgical robotics in China. The launch of the Intelligent SpinePecker robot is the direct result of this strategic collaboration, combining cutting-edge European robotics technology with local clinical development and market expertise.
