On September 3, 2024, the National Medical Products Administration (NMPA) officially approved the "Navigation and Positioning Microwave Ablation System" developed by TrueHealth (Zhuhai) Medical Technology Co., Ltd., as indicated on the NMPA's official website. This innovative system marks a significant advancement in medical device technology.
#The Navigation and Positioning Microwave Ablation System
The Navigation and Positioning Microwave Ablation System is a pioneering product from the Hengqin Deep Cooperation Zone, and it is the first to undergo the special review process for innovative medical devices in this region. This system uniquely combines puncture and ablation processes, greatly enhancing clinical accuracy in punctures, lowering the learning curve for novices, and aiding significantly in clinical ablation treatments.
The system comprises several key components:
A main control trolley equipped with a robotic arm and a foot switch,
A microwave treatment trolley featuring an optical tracking module and a foot switch,
Navigation and positioning tools,
A microwave transmission line,
Disposable microwave ablation needles,
Disposable temperature measurement needles.
This sophisticated product allows for pre-surgical planning of needle insertion based on CT images and guides the microwave ablation needle during percutaneous puncture surgeries aimed at treating solid tumors in adult livers. It represents an integration of navigation and positioning technology, respiratory tracking technology, and microwave ablation technology—a first of its kind globally. This integration results in increased precision in needle placement, ablation of target areas, and overall efficiency and success of ablation surgeries. Additionally, it reduces reliance on physicians' experience in planning punctures and ablations, thus enhancing the effectiveness and safety of treatments.
This approval marks TrueHealth's third NMPA Class III certificate for surgical robots and the second product to receive "Innovation Certification." These achievements underscore the company's robust R&D capabilities and strategic foresight in the field of interventional oncology robots.
About TrueHealth
Founded in 2018, TrueHealth is a medical surgical robot technology company that integrates artificial intelligence and robotic technology to address high-frequency medical pain points in real clinical scenarios.
The company's core product, the "TrueEase® Percutaneous Puncture Surgery Navigation and Positioning System," is the first Class III innovative medical device approved by the NMPA in the domain of soft tissue surgery robots—a domestic innovation. Deployed in dozens of hospitals, the system is used in various diagnostic and therapeutic procedures, including puncture biopsy, surgical positioning, precise ablation, and particle implantation for thoracic and abdominal organs.
To date, it has completed over 2,000 surgical cases with a 100% success rate, receiving high praise from clinical practitioners.
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