Jianxin Medical Initiates National Key R&D Program Project on Intelligent Integrated Ureteral Lithotripsy System

On June 17, the project launch meeting for the “Real-Time Adaptive Intelligent Integrated Diagnosis and Treatment System for Ureteral Stones Under Ureteroscopy” (hereinafter referred to as the “Ureteral Ultrasonic Lithotripsy System”) was successfully held in Shanghai. This project, led by Qingdao Jianxin Medical Technology Co., Ltd. (hereinafter referred to as “Jianxin Medical”) in joint application with Shanghai Sixth People’s Hospital, was approved under the 2024 National Key R&D Program’s Key Special Project on Diagnostic and Therapeutic Equipment and Biomedical Materials.

In his address, Hu Cheng, Vice President of Shanghai Sixth People’s Hospital, stated that the implementation of the “Ureteral Ultrasonic Lithotripsy System” project is expected to address clinical challenges associated with traditional treatments, such as suboptimal stone fragmentation efficacy and a high risk of complications like ureteral stricture, thereby demonstrating significant clinical value. The lead institution, Jianxin Medical, possesses internationally leading original technologies and a high-end medical device R&D, manufacturing, and production center, along with the experience and foundation necessary for implementing key R&D projects. As a collaborative partner, the Department of Urology at Shanghai Sixth People’s Hospital boasts strong scientific research capabilities and extensive experience in organizing medical device-related research initiatives, providing robust support for the project’s clinical trials and clinical applications.

Fu Qiang, Director of the Department of Urology at Shanghai Sixth People’s Hospital and the project leader, introduced that the “Ureteral Ultrasonic Lithotripsy System” features minimally invasive, precise, and intelligent capabilities compared to existing ureteral lithotripsy products. It enables accurate diagnosis and treatment of stone types using the same consumable, achieves immediate stone fragmentation, avoids thermal tissue injury, and integrates diagnosis with therapy, thereby significantly improving surgical efficiency and safety. The research and development of this project addressed key clinical pain points and achieved breakthroughs across multiple core technological dimensions:

Feng Qingyu, founder of Jianxin Medical, stated that Jianxin Medical is an innovative product R&D company characterized by “independent product definition, in-house research and development, and self-built business ecosystem.” The company has developed multiple original products in China and successfully achieved technology transfer and collaboration with numerous well-known enterprises both domestically and internationally.

This project marks the second National Key R&D Program special project led by Jianxin Medical, underscoring the company’s profound expertise and innovative strength in the field of medical device research and development. The launch of this project signifies a critical step forward for Jianxin Medical in advancing technological innovations for the diagnosis and treatment of ureteral calculi. The company has formulated a comprehensive technical plan, featuring original designs for key components such as the lithotripsy energy platform, energy emitter, and lithotripsy waveguide rod. For the first time, the project explores the relationship between acoustic impedance and the characteristics of ureteral stones, including their composition and density. By analyzing the fragmentation outcomes of ureteral stones with varying characteristics under different ultrasonic energy levels, the team has established a matching model correlating stone types with ultrasonic energy parameters, thereby enabling adaptive output of ultrasonic lithotripsy energy. This approach provides novel insights and solutions for the research and treatment of ureteral calculi. As the lead organization for this project, the company will integrate advantageous resources from all parties and strictly adhere to the project roadmap to ensure the successful technical breakthroughs and translation of achievements for the “Ureteral Ultrasonic Lithotripsy System.”

Professor Li Bin, Former Chairman of the Medical Engineering Branch of the Chinese Medical Association; Professor Cai Kui, President of the Application Evaluation Branch of the China Association of Medical Equipment; Professor Wu Xiaodong, Former Deputy Director of the Suzhou Institute of Biomedical Engineering and Technology, Chinese Academy of Sciences; Professor Meng Zhiping, Deputy Director of the Beijing Institute for Medical Device Testing; Professor Gao Xiaofeng, Deputy Leader of the CUA Stone Disease Group of Changhai Hospital Affiliated to Naval Medical University and Leader of the Shanghai Stone Disease Group; Professor Chen Qi, Deputy Leader of the Shanghai Stone Disease Group from Renji Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Professor Wu Zhong, Deputy Leader of the Shanghai Stone Disease Group from Huashan Hospital Affiliated to Fudan University; Professor Lu Jun, Deputy Leader of the Shanghai Stone Disease Group from Shanghai General Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; and Professor Wang Dawei, Deputy Leader of the Shanghai Stone Disease Group from Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, among other experts, participated in the on-site review.

The experts fully affirmed the clinical value of the project and provided pertinent recommendations regarding its implementation: At the level of technical breakthroughs, it is essential to focus on overcoming the core challenges of “adaptive intelligent diagnosis and treatment,” while also addressing the issue of thermal injury caused by spatial narrowing of the ureter. In terms of clinical application, product design should closely align with clinical practice and gold-standard diagnostic and therapeutic protocols. Comprehensive in vitro experiments should be conducted to thoroughly investigate the clinical characteristics of calculi, thereby fully validating the safety and efficacy of the product. Regarding project evaluation and promotion, it is necessary to refine evaluation metrics, clarify the clinical applicability and value of the product, incorporate ex vivo experiments into the research scope, and give full consideration to market-oriented factors. Furthermore, rigorous project proposals and evaluation plans should be formulated to ensure smooth project advancement and provide solid support for clinical diagnosis, treatment, and practical application.

Jianxin Medical is an innovative product development company centered on the sharing of technical assets, focusing on the field of high-end surgical instruments and achieving overtaking on a straight track for domestic medical devices through original Chinese innovations.

In 2022, the “Intelligent Dual-Engine Dynamic Hybrid Energy Surgical System” project, for which we served as the lead entity, was approved under the National Key R&D Program. This product enables the delivery of both electrosurgical and ultrasonic energy through a single disposable instrument, with the power output ratio between the two energy modalities dynamically adjustable based on tissue characteristics. This achieves intelligent, on-demand adaptability in clinical surgical devices. Clinical trials have officially commenced, and the product has entered the NMPA’s priority review green channel.

In 2024, the project “Integrated Intelligent Diagnosis and Treatment System for Real-Time Adaptive Ureteroscopic Lithiasis” was approved under the National Key R&D Program. This product is the first to apply a high-frequency 60 kHz ultrasound to ureteral stones, enabling intelligent identification of stone characteristics and effectively avoiding thermal injury associated with laser ureteral lithotripsy. The prototype has been completed and has officially entered registration testing.

In the same year, the project “Research on Usability Technical Evaluation of Ultrasound Surgical Systems Based on Clinical Outcomes” was approved by the Institute of Hospital Management, National Health Commission, under its Medical Engineering Program.

The Company’s proprietary ultrasonic soft tissue cutting and hemostatic device, which has been successfully commercialized, has obtained three Class III medical device registration certificates from the NMPA. It has currently been licensed for use by multiple publicly listed companies, giving rise to an authorized production business model and enabling a one-stop industrial service model encompassing independent R&D, manufacturing, and sales.

Jianxin Medical is committed to galvanizing industry strength through diversified collaboration and the sharing of technological assets, jointly promoting innovation in the medical device industry. In 2024, it jointly established the “High-End Medical Device R&D and Manufacturing Center” with Foxconn Industrial Internet’s subsidiary, FULIAN Yukang Medical Technology (Shenzhen) Co., Ltd., creating a “full-chain” R&D and manufacturing model that lays a solid foundation for supply chain and production operations, ensuring international product quality. Together with the China Technology Exchange, the Liaoning Provincial Medical Device Testing Institute under the National Medical Products Administration, Kesun Technology Co., Ltd., and Qingdao Innovation Investment Co., Ltd., it founded the Medical Device Innovation Research Institute to leverage product R&D and innovation capabilities, driving the innovative development of high-end medical devices in China. Additionally, in partnership with internationally renowned companies and several domestic listed firms, it has developed multiple innovative surgical products, jointly building integrated smart operating rooms for diagnosis and treatment, pioneering an “integrated” operating room scenario construction model, and establishing a full-chain industrial ecosystem spanning the entire lifecycle of medical devices.

In the future, Jianxin Medical will remain committed to driving clinical transformation through innovation, conducting product R&D guided by clinical pain points, and striving to build a true “integrated diagnosis and treatment” closed-loop clinical application, thereby promoting the development of domestically produced medical devices toward greater perceptiveness and intelligence.