China MedTech Weekly Highlights [Dec 29 – Jan 4]: Innovations, Fundings, and Regulatory Advances

Recently, Comen Biotech and the School of Pharmacy at Xi'an Jiaotong University strategically partnered, achieving key progress in the field of in vitro diagnostic fluorescent dyes. Through joint efforts, a new fluorescent dye molecule for reticulocyte and nucleated red blood cell detection has completed its core patent layout and has been successfully applied to a new generation of fluorescent reagent products. In reticulocyte detection technology, the research team improved the dye’s fluorescence performance, anti-interference capability, and hydrophilicity through molecular structural innovation. For nucleated red blood cell detection, they achieved "one-dye dual detection," with leading staining effects, higher specificity, and convenient, efficient application. Currently, core patents based on these two innovative technologies have been submitted for application, and the new fluorescent dye has been successfully applied to Comen Biotech's CF9600 fully automatic hematology analyzer, realizing full-process independent development. Both parties expressed their intention to deepen cooperation and advance more research projects.

Recently, according to Sichuan Online, the orthopedics team of Zeng Jiancheng from West China Hospital of Sichuan University completed a robot-assisted minimally invasive oblique lateral lumbar interbody fusion combined with anterior fixation. The 62-year-old patient, Li Dong, underwent lumbar fixation and fusion surgery 15 years ago and has experienced persistent lower back pain in recent years, being diagnosed with "adjacent segment disease after L4-S1 fusion." Zeng Jiancheng's team adopted an innovative surgical approach, focusing on the dual core concepts of "precision" and "minimally invasive." Relying on a three-dimensional navigation system, the robot controlled the screw implantation error within a sub-millimeter range, enhancing the precision and safety of the surgery. With a 5-centimeter incision that avoided the previous surgical scar area, blood loss during the operation was less than 10 milliliters, resulting in minimal trauma. Two hours after the surgery, the patient was able to walk with the aid of a brace, and was discharged smoothly after 12 hours.

Recently, during the 20th anniversary meeting of Meditech, the joint venture established with UBTECH Robotics officially launched the Youmai Health Companion Robot V1.0, marking a new leap in medical technology towards embodied intelligence using fully autonomous and controllable technology. According to Chief Technology Officer Fan Xiaofeng, the product focuses on the three core pain points of the elderly population: "loneliness, health, and safety." It will feature AI voice chat, medication reminders, remote appliance control, millimeter-wave vital signs monitoring, intelligent calling, and emergency alerts. The Youmai Health Companion Robot has recently completed trial deployment at Suzhou Social Welfare Institute and Zhejiang Taizhou Rehabilitation Hospital, with a price tag of 50,000 yuan. Notably, the first CR certification for health companion robots was simultaneously launched at the release event, advanced in collaboration with the Shanghai Robotics Industry Technology Research Institute.

Recently, the "Beijing Surgy Robotics Surgical Innovation Demonstration Center" was established. Surgy completed the signing of leasing its endoscopic surgical robot into hospitals, becoming the "icebreaker" in the leasing model within the endoscopic surgical robot field. Through the "government-backed leasing platform" model, it achieves a win-win situation for all parties involved. As the leading company in the medical equipment industry, United Imaging established Shanghai United Imaging Medical Equipment Leasing Co., Ltd. in 2024, elevating financial leasing to a core strategic level. By introducing third-party financial institutions, it realizes "risk isolation" and "cash flow optimization." Relying on the professional operation and meticulous risk management of the leasing company, it effectively enhances market penetration and profitability. Surgy, United Imaging, and Tinavi are the three pioneering companies that jointly open up a new leasing track for ultra-high-end medical equipment.

Recently, at the 2025 Hainan Free Trade Port Global Pharmaceutical and Device Innovation Introduction and China's New Outbound Hub Conference, it was announced that Guochen Medical plans to invest 150 million yuan over the next five years to build the "Guochen Hainan Global Service Center." This will add an annual production capacity of 1,500 X-ray tubes, with over 300 units exported or transshipped for installation. A complete industrial chain support system will be formed to serve more than 4 billion people globally. The project has been officially signed and will be located in Haikou National High-Tech Industrial Development Zone. Founded in 2023, Guochen Medical focuses on the independent research, development, and production of core components for imaging equipment. Its business covers third-party X-ray tube replacements, whole-unit OEM services, and high-end custom development. The founders, Ren Guotao and co-founder Wang Xiaoxing, have deep technical expertise, having established a comprehensive R&D system. A production base has been built in Wuxi, Jiangsu, with an annual designed capacity of over 5,000 units.

Recently, Suzhou Yacoo Technology Co., Ltd. and Shenzhen Mindray Bio-Medical Electronics Co., Ltd. officially signed a strategic cooperation agreement. During the signing ceremony, the senior management of both parties reviewed key aspects such as the supply assurance and technical compatibility of cooperative products like raw materials for in vitro diagnostic reagents. They acknowledged the virtuous cycle model of "demand-customized development-testing verification-high-quality stable supply" from past collaborations. In the future, both parties will focus on areas such as artificial intelligence + healthcare and high-end diagnostic technology innovation, deepen R&D collaboration, and accelerate the launch of new products like highly sensitive detection reagent materials. At the same time, they will optimize the supply chain system and enhance global supply responsiveness. Joint industrial efforts for deep integration.

Recently, Infervision Medical and Intuitive Fosun reached a strategic partnership, focusing on the key nodes of "preoperative to intraoperative" in surgical diagnosis and treatment, exploring the deep application of AI in surgical robot scenarios. By combining Infervision's capabilities in AI-based 3D reconstruction and preoperative planning with Intuitive Fosun’s system platform advantages in the surgical robotics field, the collaboration aims to enhance the visualization and decision-support capabilities for complex surgeries. It provides doctors with more definitive preoperative insights and lays a high-quality data foundation for precise execution by surgical robots. By integrating AI into the preoperative phase of surgery, Infervision Medical helps doctors gain more intuitive and quantifiable anatomical and lesion information, improving the scientific rigor and consistency of surgical planning. Chen Kuan, Founder and Chairman of Infervision Medical, stated that this cooperation will promote the seamless integration of AI into surgical clinical workflows, marking an important exploration in intelligent minimally invasive surgery. He expressed his anticipation of working with Intuitive Fosun to extend the benefits of intelligent technology to more clinical scenarios.

On December 29, the "Building a Strong Nation: China Manufacturing '14th Five-Year Plan' Achievements Exhibition" opened at the National Museum of China. As a representative enterprise of China's high-end medical equipment, Mindray showcased five innovative products in the "Better Life" exhibition area, comprehensively demonstrating the independent innovation capabilities of China's medical industry across life information and support, in-vitro diagnostics, medical imaging, and minimally invasive surgery.

Recently, the Anhui Provincial Drug Administration issued and implemented the "Anhui Province Medical Device Production Supervision and Inspection Work Specification (Trial)" to build a new pattern. A four-party linkage constructs a new layered supervision pattern: the provincial bureau oversees, the branch bureaus take charge of operations, the municipal bureaus bear primary responsibility, and the center coordinates. A five-dimensional supervision model is established, including "routine + key-point + cause-based + follow-up + special" inspections, implementing graded and categorized precision supervision, promoting consolidated inspections, conducting full-item annual inspections for high-risk enterprises, promptly initiating cause-based inspections, and setting up a "follow-up inspection回头看 mechanism." A six-step standardized process is built, covering "plan formulation—scheme approval—on-site inspection—conclusion determination—post-inspection handling—information disclosure," emphasizing key points, implementing穿透式监管 (penetrative supervision), improving credit supervision, clarifying information disclosure, and establishing mechanisms for cross-jurisdictional inspection result sharing to promote a co-governance pattern.

Recently, the Shanghai Municipal Commission of Commerce and other 16 departments issued the "Several Measures to Further Expand Service Consumption in Shanghai." According to the Measures, it proposes to enhance the international level of health consumption. Encourage physical examination institutions to extend into specialized disease examinations and pre- and post-examination services. Apply advanced treatment methods such as cell therapy and brain-computer interfaces to promote the clinical use of innovative technologies and medical devices. Encourage qualified medical institutions to carry out specialized international medical projects. Guide the diversified development of the health industry and address shortages in rehabilitation and nursing resources. Support privately-run medical institutions in providing international medical services. Encourage medical institutions to collaborate with commercial insurance companies to conduct direct settlement of commercial health insurance. Encourage commercial insurance companies to develop health insurance products that connect with specialized medical services and cross-border medical insurance products.

Recently, the Anhui Provincial Health Commission and three other departments jointly released a "New Quality Medical Devices and Pharmaceuticals" product directory to accelerate the promotion and application of innovative pharmaceutical products and drive the implementation of innovative achievements. Of the 60 products listed in the directory, 45 are from Hefei, accounting for 75% of the province, highlighting the city's innovation strength and clustering effect in the biopharmaceutical industry. In terms of biologics, all three selected biologic products in the province come from Hefei and are self-developed; in the chemical pharmaceuticals sector, Hefei companies secured 81% of the provincial projects; in medical devices, 23 out of the 24 selected products are from Hefei, covering multiple fields. In recent years, the Hefei Municipal Industry and Information Technology Bureau has promoted innovation in the biopharmaceutical industry by building a collaborative ecosystem involving government, industry, academia, research, application, and finance. The focus has been on nurturing local leading enterprises, attracting innovative companies through high-level platforms, and incubating technology-based small and medium-sized enterprises in collaboration with universities and research institutes, forming a favorable pattern of integrated development among large, medium, and small enterprises.

Recently, the National Medical Products Administration (NMPA) announced the "Priority Approval Directory for High-End Medical Devices (2025 Edition)," which took effect upon publication and will be adjusted as needed. The NMPA will implement priority approval for registration applications of medical devices listed in the directory according to relevant procedures. Applications proposed by the Center for Technical Evaluation for priority approval will enter the process after public announcement without objections; otherwise, reasons will be provided, and the application will proceed under the standard procedure. Included in the directory are: Boron Neutron Capture Therapy Systems for malignant tumor treatment, Ultra-High Field Magnetic Resonance Imaging equipment with magnetic field strength ≥5T, Medical Linear Accelerators integrated with MRI guidance, Implantable Brain-Computer Interface medical devices for compensating multiple functional impairments or disease intervention, Endoscopic Surgery Control Systems utilizing robotic technology, Transcatheter Tricuspid Valve Replacement or Repair Systems suitable for high-risk patients, and Membrane Oxygenators for cardiopulmonary support.

Shandong Provincial Government General Office Releases "Implementation Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Supervision to Promote High-Quality Development of the Pharmaceutical Industry," Containing 29 Articles, Covering the Entire Chain of Medical Device Research and Development, Approval, Hospital Entry, and Payment. Including support for cutting-edge technology layouts, providing R&D subsidies for innovative drugs and high-end medical devices, and strengthening strategic investment in pharmaceutical potential enterprises and high-quality R&D pipelines through various methods; promoting the application of artificial intelligence in clinical trials, encouraging medical institutions to register as clinical trial institutions; launching the "Spring Rain Action" to focus on supporting fields such as AI-assisted diagnostic equipment, implementing a green channel mechanism for innovative drug and device listings, completing reviews and listing within 15 working days; encouraging medical institutions to procure and use innovative drugs and devices covered by medical insurance payments, incorporating qualified innovative medical consumables into the scope of medical insurance payments. In addition, recently, the central government and multiple regions have issued supportive policies intensively, accelerating the entry of innovative products into hospitals.