NDR Medical Technology, a Portfolio Company of MicroPort® MedBot™, Wins FDA 510(k) Clearance for its ANT-X™ Automatic Robotic Device

Singapore, 17 July 2023 – Recently, NDR Medical Technology Private Limited (hereinafter referred to as "NDR"), a portfolio company of Shanghai Microport MedBot (Group) Co., Ltd. (hereinafter referred to as "MicroPort® MedBot™"), has announced that its automated robotic device, Auto Needle Targeting system (hereinafter referred to as "ANT-X™"), has been granted FDA 510(k) clearance by the U.S. Food and Drug Administration (FDA). This clearance makes ANT-X™ the world's first FDA-approved C-arm guided Percutaneous Nephrolithotomy (PCNL) robotic device. Prior to that, ANT-X™ received the CE mark in 2020.

As the first C-arm imaging and AI software integrated robotic device launched by NDR, the ANT-X™ system is designed to assist clinicians in carrying out PCNL procedures safely and effectively. Precise needle placement is a crucial step in this kidney stone removal procedure. To achieve this, ANT-X™ fully automates the processes of system calibration and needle placement calibration. This function helps reduce the procedure's difficulty, shorten the learning curve for clinicians, improve the accuracy of needle position, and reduce surgical complications. It is compatible with all types of C-arm machines and can be widely used in interventional surgeries that require percutaneous needle placement, such as urology, neurology, orthopedics, etc., especially in the treatment of common diseases such as herniated discs.

Mr. Liu Yu, Executive Vice President and Chief Commercial Officer of MicroPort® MedBot™, said, "With the development of technology, surgical robots have higher precision, consistency, and manipulability. Compared to traditional minimally invasive surgery, they can effectively reduce the burden on clinicians, improve the success rate of surgery, reduce the size of surgical incisions, and shorten the patient's postoperative recovery period. We hope that our surgical robotic products, such as Toumai™, Honghu, Mona Lisa, R-One™, ANT-X™, and others, can be increasingly applied in clinical practice in the current context of continuously increasing demand for high-quality medical resources to solidify their value, benefit patients worldwide, and make surgeries easier all over the world."