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MicroPort® MedBot™ Receives TGA Approval for its SkyWalker™

Skywalker-System-MicroPort

The SkyWalker™ Orthopaedic Surgical Robot, developed by Suzhou MicroPort NaviBot (Suzhou) Co., Ltd., a subsidiary of Shanghai MicroPort MedBot (Group) Co., Ltd. (MicroPort® MedBot™) has officially passed the review of the Australian Therapeutic Goods Administration (TGA) and Australian Register of Therapeutic Goods (ARTG). It has been approved to go on the market in Australia.

This has been another significant breakthrough for SkyWalker™ after it obtained registration certification from the National Medical Products Administration (NMPA) of China, the US Food and Drug Administration (FDA), the European Union’s CE certification, and the Brazilian National Health Surveillance Agency (ANVISA). MicroPort® MedBot™ has planned to use this opportunity to benefit more patients globally through technological innovation.

SkyWalker™, which has taken years to develop, has currently been certified and listed simultaneously in Asia, North America, Europe, South America, and Australia. It is equipped with a self-developed robotic arm and can be used to assist in total knee arthroplasty (TKA). SkyWalker helps provide integrated orthopedic colutions for patients by assisting surgeons with preoperative CT scanning, establishing three-dimensional models, generating personalized implantation plans, robotic arm registration, bone registration, navigational positioning, precise bone cutting, and prosthesis installation.

In recent years, SkyWalker™ has continuously challenged high-difficulty surgical procedures, assisting clinical experts in achieving numerous breakthroughs. Up to now, SkyWalker™ has completed more than 600 robot-assisted clinical surgeries in orthopedic, joint surgery, and sports medicine departments. This includes several first and high-difficulty robot-assisted surgeries, such as femoral shaft fracture, intramedullary nail fixation post-surgery joint replacement, and severe rheumatoid arthritis joint replacement surgery. It has also assisted medical personnel in performing total knee joint replacement surgery in high-altitude and cold environments, demonstrating a high level of stability in its auxiliary role.

According to Mr. Yu Liu, Executive Vice President and Chief Business Officer of MicroPort® MedBot™, “The approval [of the SkyWalker™ Orthopedic Surgical Robot] will help MicroPort® MedBot™ accelerate its global footprint, benefit more global patients, and realize its initial ambition to ‘Make Surgery Easier, Safer and Less Invasive'”.

Source: MicroPort

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