Jianxin Medical Secures Second National Key R&D Program Grant for Innovative Ureteral Lithotripsy System

Recently, Qingdao Jianxin Medical Technology Co., Ltd. (hereinafter referred to as “Jianxin Medical”) independently developed"Real-Time Adaptive Intelligent Integrated Diagnosis and Treatment System for Ureteroscopic Lithiasis"(abbreviated as “Ureteral Ultrasonic Lithotripsy System”) has successfully obtained2024 National Key R&D Program Project Approval! This marks the second time that Qingdao Jianxin Medical Technology Co., Ltd. has received this honor, following the inclusion of its “Intelligent Dual-Engine Dynamic Hybrid Energy Surgical System” in the National Key R&D Program in 2022. This achievement not only signifies a major breakthrough for the company in the field of urinary stone treatment but also serves as recognition of its innovation model, which has long been driven by addressing clinical pain points and aimed at sharing technological assets.

As a domestically developed original product, the “Ureteral Ultrasonic Lithotripsy System” features high precision, efficient stone fragmentation, and no thermal injury, thereby filling a gap in both the domestic and international markets in this field.

Urinary stones are a common urological condition, with ureteral stones accounting for 33%–54% of all urinary tract stones. The global prevalence ranges from 4% to 15% and continues to rise. However, traditional ureteral lithotripsy methods—such as extracorporeal shock wave lithotripsy (ESWL), transurethral laser lithotripsy, and transurethral pneumatic ballistic lithotripsy—are associated with low stone fragmentation efficiency, significant thermal injury, and complications such as ureteral stricture. These limitations have become major challenges in clinical diagnosis and treatment, posing considerable difficulties for patient management.

The emergence of the minimally invasive, precise, and intelligent “Ureteral Ultrasonic Lithotripsy System” provides a novel and highly efficient treatment option for patients with urinary calculi. This system enables accurate diagnosis of stone composition and subsequent treatment using the same disposable consumable, achieving immediate stone fragmentation while avoiding thermal tissue injury. By integrating diagnosis and therapy into a single procedure, it significantly enhances surgical efficiency and safety. Compared with existing ureteral lithotripsy products, the “Ureteral Ultrasonic Lithotripsy System” demonstrates distinct advantages in terms of lithotripsy efficiency, fragmentation efficacy, complication reduction, and cost-effectiveness, indicating broad market prospects.

Focusing on the clinical pain points of ureteral lithotripsy, this project prioritizes research on four key technologies:

The successful project initiation underscores Jianxin Medical’s exceptional capabilities in the innovative research and development of medical devices. It is reported that the company’s team conducted key indexing and in-depth analysis of over 1,200 valid patents held by urologists, revealing that the lack of precise, effective, and non-thermal-damage treatment options for ureteral calculi represents one of the most prominent clinical pain points currently, urgently necessitating innovative products to drive procedural innovation.

Based on this, the company has defined the innovative R&D direction for its “Ureteral Lithotripsy System” and formulated a comprehensive technical solution. It conducted original design work on key components, including the lithotripsy energy platform, energy emitter, and lithotripsy waveguide rod. For the first time, it explored the relationship between ureteral stone characteristics—such as composition and density—and acoustic impedance. By analyzing the fragmentation outcomes of ureteral stones with varying characteristics under different ultrasonic energy levels, the company established, for the first time, a matching model correlating ureteral stone types with ultrasonic energy, thereby enabling autonomous detection and identification of stone properties and morphology. Furthermore, an ultrasonic energy control system was designed based on this model to achieve real-time adaptive lithotripsy under ureteroscopy, providing new insights and solutions for the research and treatment of ureteral stones.

This clinical pain point-centered patent analysis system serves as the driving force behind Jianxin Medical’s source innovation, establishing a proprietary product R&D innovation model unique to the company. To date, Jianxin Medical has completed structured analysis of over 170,000 clinical invention patents. By categorizing data according to anatomical site and disease, it indexes key information such as medical device classification, indications, and technical efficacy. This approach enables an in-depth examination of technological development trends and unresolved challenges within specific subfields, resulting in original analytical reports across various domains, including urology, dentistry, orthopedics, and neurosurgery. For the first time, a patent analysis system centered on clinical pain points has been established, creating an innovation model where patent analysis drives product R&D, thereby guiding industry innovation with a focus on real-world clinical needs.

Securing two projects under the National Key R&D Program marks a solid step forward for Jianxin Medical in the field of medical device innovation. The company will continue to uphold its philosophy of “achieving leapfrog development in medical devices through original Chinese innovations,” constantly launching more innovative products with independent intellectual property rights, and driving continuous innovation and high-quality development in China’s domestic medical device industry.

As an innovative product R&D company centered on “shared technical assets,” Jianxin Medical has consistently adhered to driving clinical transformation through innovation, conducting product innovation and development guided by clinical pain points. Focusing on the R&D of minimally invasive surgical treatment equipment and visualized surgical platforms, the company is committed to building a closed-loop clinical application system integrating diagnosis and treatment, thereby promoting the development of domestically produced medical devices toward perception-enabled and intelligent solutions.

Currently, the company has successfully developed multiple original products. Its first anti-adhesion ultrasonic energy system for 5mm vessel cutting and hemostasis has obtained the NMPA Class III medical device registration certificate, has been applied in various domestic surgical robots, and has established technical collaborations with several internationally renowned enterprises. Meanwhile, multiple products under development are gradually being introduced into clinical practice, including: an originally developed intelligent dual-engine dynamic hybrid energy surgical system suitable for different clinical scenarios, which has been approved as a special project of the National Key R&D Program and entered the NMPA’s priority review green channel; this system can output electrical and ultrasonic energy in real time using the same disposable instrument according to tissue characteristics during clinical surgery, achieving intelligent “on-demand adaptability” of the equipment; an originally developed dual-probe, dual-plane 3D ultrasound visualization surgical platform that simultaneously addresses the challenges of “temporal precision” and “spatial precision” in interventional procedures; and an originally developed multifunctional coagulation and suction system capable of performing clamping, irrigation, suction, and coagulation across all surgical scenarios.

Jianxin Medical has been committed to galvanizing industry strength through diversified collaboration and the sharing of technological assets, jointly promoting innovation in the medical device industry. The company has established a Medical Device Product Innovation Center in partnership with authoritative institutions such as the China Technology Exchange and the Liaoning Provincial Institute for Medical Device Inspection and Testing, driving the chain-based, diversified, and systematic development of medical device innovation. Together with Foxconn Industrial Internet’s subsidiary, Fulian Yukang Medical Technology (Shenzhen) Co., Ltd., it has founded the “High-End Medical Device R&D and Manufacturing Center,” creating an “end-to-end” R&D and manufacturing model that fosters collaborative innovation and provides full-stack, original product-level solutions to the global market. In collaboration with internationally renowned enterprises and several domestic listed companies, Jianxin Medical has developed multiple innovative surgical products and jointly built integrated smart operating rooms for diagnosis and treatment, pioneering an “integrated” operating room scenario construction model and establishing a comprehensive industrial ecosystem that spans the entire lifecycle of medical devices.