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Honghu Orthopedic Surgical Robot Approved by Brazilian Health Supervision Authority
2023-05-05 GMT+8 PM 08:40

On April 23, 2023, the Honghu Orthopedic Surgical Robot (overseas SkyWalker™, hereinafter referred to as Honghu) developed by MicroPort NaviBot (Suzhou) Co., Ltd., a subsidiary of Shanghai MicroPort MedBot (Group) Co., Ltd. passed the review of the Brazilian Health Supervision Authority (ANVISA) and was approved to be marketed in Brazil. This is another breakthrough achievement created by Honghu following the marketing approval from the National Medical Products Administration (NMPA) in April, the U.S. Food and Drug Administration (FDA) in July, and the EU CE certification in December last year. Honghu has been consecutively certified in China, the United States, the European Union and Brazil, which indicate the rapid development of China's surgical robot industry and will accelerate the globalization strategy of MicroPort® MedBot® and help surgical robot techniques benefit more patients worldwide.

 

As the pioneer of medical robots in China, MicroPort® MedBot® has spent years in creating the Honghu Orthopedic Surgical Robot, which is the first and only Chinese-developed surgical robot that has been certified by NMPA, FDA, CE, and ANVISA. It enables joint replacement with a robotic arm guided by CT images.

 

In recent year, Honghu has continuously challenged difficult surgical procedures and assisted clinical experts to achieve many breakthroughs. Up to now, Honghu Orthopedic Surgical Robot has completed more than 500 robotic-assisted clinical verification surgeries in orthopedics, joint surgery and sports medicine departments of 27hospitals in15 provinces and municipalities in China, including many first and difficult robotic-assisted surgeries, such as the first Chinese-developed surgical robot 5G-based remote joint replacement, joint replacement after intramedullary nail fixation for femoral shaft fracture, and joint replacement surgery for severe rheumatoid arthritis. In its international cause, Honghu Robot has been successfully used in dozens of total knee replacement surgeries at U.S. hospitals, including Lighthouse Surgical Hospital in New Hampshire, USA since November 2022. It marks the gradual maturity of Honghu Orthopedic Surgical Robot in clinical application to meet the clinical requirements of orthopedic surgery robots and help hospitals to make continuous high-quality progress in research.

 

Mr. Yu Liu, Executive Group Vice President and Chief Commercial Officer of MicroPort® MedBot® said, "The original intention of MicroPort® MedBot® is to make surgery easier, safer and less invasive. With the regulatory approval from Anvisa in Brazil, we will enter the market quickly to provide local surgeons and hospitals with more comprehensive robot-assisted surgery solutions. We are looking forward to working with our local partners to expand our presence in Latin America to provide better and more reliable medical technology services to more patients."

 

1 The registered trademark of HongHu is named “Skywalker” in abroad, which is in the process of application in USA, completed registration in EU and other countries and regions.

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