The Sino-European MicroRobotics (Shanghai) (SEMR) joint venture (JV) has obtained regulatory approval for the Intelligent SpinePecker miniature spinal surgical robot in China.
Comprising Austrian company Interventional Systems and China-based HICREN, the JV has been granted Class III Medical Device Registration by the China National Medical Products Administration (NMPA) for the 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 in February 2024.
The Intelligent SpinePecker utilises Interventional Systems’ Micromate robotic technology and is said to feature a palm-sized robot arm that weighs 1.63kg.
The system is incorporated into a mobile console with a 0.32m² footprint and can be set up in less than ten minutes.
In terms of performance, the robot is said to have a positioning accuracy of 0.2mm, and it has been engineered to streamline surgical procedures, potentially decreasing the time spent in surgery, with the capability of placing one pedicle screw in as little as one minute.
The system’s intelligent algorithms aid in simplifying the surgical planning process, offering a reduced learning curve for medical professionals.
The launch of the Intelligent SpinePecker is scheduled for next month.
Interventional Systems managing director and founder Dr Michael Vogele said: “Interventional Systems is excited about the cooperation and partnership with HICREN/SEMR. Through outstanding cooperation, our teams have been able to conceptualise, 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 a 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.”
HICREN and SEMR general manager and chairman MA Yan said: “[This approval] marks its official entry into clinical application. It represents a significant milestone in China’s advancement toward minimally invasive orthopaedic 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.”
source: medicaldevice
