Shanghai MicroPort's "Toumai" Surgical Robot Completes First Remote Surgery in the United States

Recently, the "Toumai" surgical robot developed by Shanghai MicroPort MedBot Group helped a medical team complete the first remote surgery in U.S. history in Florida. This surgery was conducted under the U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical research framework, between two hospitals in Florida 56 kilometers apart, and was a radical prostatectomy. The surgery took 103 minutes, with no lag throughout, almost no visible bleeding during the procedure, and smooth two-way voice communication. "Toumai" remote coverage spans the full range of clinical applications in urology, general surgery, thoracic surgery, and gynecology. It has an advanced imaging system that can provide a high-definition field of view with 10x optical magnification and achieve naked-eye 3D imaging. The robotic arm system that performs surgical operations has 7 degrees of freedom and can stably filter out the physiological tremors of surgeons' hands. The wrist-rotatable surgical instruments provide flexibility, precision, and stability beyond human hands, and can assist doctors in completing a variety of highly difficult operations within narrow cavities. Last April, "Toumai" remote received marketing approval from China's National Medical Products Administration. In overseas market expansion, this remote robot has completed the country's first remote surgery in more than 20 countries and has been approved by regulatory authorities in nearly 60 countries and regions. As clinical evidence, regulatory frameworks, and infrastructure related to remote surgery continue to improve globally, domestic robots are expected to become an important choice for surgical experts in various countries to carry out cross-regional medical collaboration, share high-quality surgical resources, and innovate global surgical service models. Patel performed the remote surgery at a console located in Orlando. In the United States, Dr. Vipul Patel, founder and president of the Global Robotics Surgery Association, recently operated the "Toumai" robot to complete the first remote surgery in the United States. He performed the surgery at a console located in Orlando, while Dr. Marcio Moschovas's team provided on-site support at a hospital in Minneola, 56 kilometers away. The patient underwent remote surgery at a hospital in Minneola. During the surgery, Patel rotated his fingers and wrists and pressed control pedals with his feet. The robotic arms of the "Toumai" robot followed closely and precisely executed every instruction—dissection, cutting, electrocoagulation, and hemostasis—completely removing the diseased prostate. After successfully completing the surgery, Patel said: "This clinical study allows us to evaluate whether remote surgery may in the future help reduce the geographic barriers faced by specialized treatment. Important questions regarding safety, effectiveness, and technical performance will continue to be studied in subsequent surgeries." ABC News described the surgery in its report as "a milestone in remote surgery." It is understood that the United States is the country with the most mature surgical robot industry development and the largest market size in the world, but in the field of remote surgery, its domestic companies are still in the stage of technological exploration, and there have been no human clinical application cases. The Shanghai company's conduct of the FDA IDE clinical study in the United States fills this gap. ABC News report footage of the first remote surgery in the United States. MicroPort MedBot Group explained that the IDE framework allows investigational devices that meet regulatory requirements to be used in clinical research to collect safety and effectiveness data. The relevant data can be used to support subsequent FDA Premarket Approval (PMA) applications; in some Premarket Notification (510(k)) applications that require clinical data, it can also serve as supporting evidence.