Interventional Systems, HICREN get regulatory nod for mini spine surgical robot in China

Interventional Systems and HICREN today announced approval for their joint venture’s surgical robot platform in China.

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.

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