The two companies collaborated as a joint venture — Sino-European MicroRobotics (SEMR) to develop a spinal surgical navigation and positioning system. They said today that they received Class III Medical Device Registration approval from the China National Medical Products Administration (NMPA). This follows fast-track entry into the NMPA’s innovative medical device expedited review pathway last year.
According to Austria-based Interventional Systems and China-based HICREN, it marks the first approval for a miniature orthopedic surgical robot in China. The system, commercially known as the Intelligent SpinePecker, aims to meet the demands of modern surgery.