Medical Device Weekly Highlights (March 31 – April 6): Regulatory Approvals, Funding Rounds, and Strategic Expansions

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46 Color Doppler Ultrasound Systems Purchased Through Centralized Procurement Are All Made in China

"Eye-Hand-Brain" Interventional Surgical Robot Born in Beijing Yizhuang

Recently, Lumiradx Technology announced that its wholly-owned subsidiary, Anhui Puhé Biotechnology Co., Ltd., signed the "Standard Land Investment and Construction Agreement for Industrial Projects in Hexian Economic Development Zone" with the Management Committee of Hexian Economic Development Zone in Anhui. The agreement aims to advance the "In Vitro Diagnostics Reagent Industrialization Project" by Anhui Puhé, with an estimated total investment of 1 billion yuan, including approximately 600 million yuan in fixed asset investment. Located just over 100 kilometers from Lumiradx's Nanjing R&D headquarters, Anhui Hexian holds a significant geographical advantage. Upon completion of the project, innovative achievements from the Nanjing base can be quickly transferred into production, shortening the product’s time to market. Additionally, Hexian has already established a biopharmaceutical industry cluster, and policy support along with industrial resources will further help Lumiradx reduce costs and increase efficiency.

Recently, Restore Robotics announced that it has obtained 510(k) clearance from the U.S. Food and Drug Administration (FDA) to remanufacture the da Vinci Xi Monopolar Scissors. Achieving this milestone on March 11, 2025, through its subsidiary Iconocare Health, Restore Robotics provides hospitals and surgical centers with a cost-effective and sustainable alternative to purchasing instruments from the original equipment manufacturer. Through a marketing and distribution partnership with Encore Medical Device Repair (Encore), Restore Robotics is able to efficiently deliver remanufactured surgical instruments to hospitals and surgical centers across the United States, expanding access to affordable, high-quality surgical tools.

Recently, Keeler, a well-known ophthalmic medical device brand under the British Halma Group, announced the official completion and commencement of operations of its manufacturing base in China. This move marks Keeler's full initiation of its localization strategy, further enhancing its competitiveness in the Chinese market while injecting new vitality into China's ophthalmic medical industry. From project planning to final implementation, Keeler’s "China factory" underwent several critical stages including technology transfer, factory construction, product registration, and production licensing. The factory is equipped with an extremely strict quality management system to ensure that every piece of equipment produced meets the requirements of the national medical device quality management system. Each step, from raw material procurement to finished product delivery, is rigorously inspected to fully guarantee the professionalism and high quality of the products.

Recently, Guangzhou Kangrun Biotechnology Co., Ltd. showcased its "Trinity" immunodiagnostic smart lab solution along with multiple new products at the China International Laboratory Medicine and In Vitro Diagnostics Reagents Expo (CACLP). Kangrun seamlessly integrated its three core technology platforms: the fully automatic indirect immunofluorescence analyzer (Quant IFA2000), the fully automatic chemiluminescence immunoassay analyzer (Kaeser 8800), and the fully automatic immunoblot analyzer (HiLIA 1500). The "Trinity" encompasses three dimensions: 1. Disease diagnosis and treatment integration as the guiding principle; 2. Standardized testing, intelligent management, and smart analysis as the core concept; 3. Fluorescence screening, multi-identification, chemiluminescent follow-up testing, and monitoring as the foundation. This solution breaks through the limitations of traditional labs, such as "homogeneous combination models, scattered equipment, and cumbersome processes," offering core features of extreme speed, simplicity, and intelligence. It flexibly adapts to the needs of labs of different sizes, providing a one-stop solution for clinical cost reduction, efficiency improvement, result mutual recognition, and diagnostic upgrades.

Recently, the signing and unveiling ceremony of Medtronic's Digital Healthcare Innovation Base was held at the International Pharmaceutical Innovation Park (BioPark). This marks the establishment of Medtronic’s first digital healthcare innovation base in China, signifying a new chapter in its development in Beijing. The base is dedicated to developing disease management solutions based on artificial intelligence and big data, with a focus on building medical training centers in areas such as cardiovascular, minimally invasive surgery, and neuroscience. It will also establish a patient care center, integrating digital technologies to enhance the level of preventive care services for patients. Additionally, a Medtronic museum will be constructed. The innovation base is set to officially commence operations by the end of this year.

Recently, the Hubei Provincial Medical Insurance Bureau released the "Brain-Computer Interface Medical Service Prices." The fee for invasive brain-computer interface implantation is 6,552 yuan per session, the removal fee for invasive brain-computer interfaces is 3,139 yuan per session, and the fitting fee for non-invasive brain-computer interfaces is 966 yuan per session. The Hubei Provincial Medical Insurance Bureau aligned with the "Guidelines for the Establishment of Neurological System Medical Service Price Projects (Trial)" to implement pricing projects for "invasive brain-computer interface implantation fees," "invasive brain-computer interface removal fees," and "non-invasive brain-computer interface fitting fees," establishing government-guided prices. According to the announcement, the project prices are the maximum allowable rates in the province, with no upward adjustments permitted, while downward adjustments are unrestricted. This move provides policy support for the clinical application of brain-computer interface technology, promoting the transformation of high-level medical innovation achievements into clinical practice.

Recently, the "New Momentum of Medical Devices · Partner Ecosystem Co-construction and Unveiling Ceremony of Three Exhibition Centers of Guolan Medical Device City" was held in Liwan, Guangzhou. This event was hosted by Guangzhou Guolan Medical Device City, organized by the Guangdong Food and Drug Review Technology Association, and supported by the Liwan District Market Supervision Administration and the Liwan District Science, Industry, and Information Technology Bureau. Through a "three-in-one" model of exhibition center unveiling, cooperation signing, and industrial policy promotion, the event comprehensively showcased the innovative vitality and development potential of Liwan's medical device industry cluster. At the event, three exhibition centers were officially unveiled: the Liwan Medical Device Brand Exhibition Center, the Foreign Trade Export Medical Device Exhibition and Trading Center, and the Rehabilitation Home-use Device and Wearable Device Exhibition and Trading Center. These three exhibition centers will respectively undertake the core functions of "benchmarking international standards," "building a dual circulation pattern," and "serving the silver economy." By creating a high-end exhibition platform, an international trading hub, and a smart health experience center, they will promote the transformation of Liwan's medical device industry towards high-end, international, and intelligent development.

Recently, the National Medical Products Administration (NMPA) has approved the marketing applications of four innovative medical devices. They are: "Cardiac Pulsed Field Ablation System" and "Single-Use Cardiac Pulsed Field Ablation Catheter" from Tianjin Yingtai Li Ankang Medical Technology Co., Ltd., as well as "Cardiac Pulsed Field Ablation Device" and "Single-Use Magnetically Guided Cardiac Pulsed Field Ablation Catheter" from Shanghai Shangyang Medical Technology Co., Ltd.

Recently, the Intellectual Property Big Data Service in the Field of Medical Devices in Guangzhou City has been officially launched. Under the guidance and support of the Guangdong Institute of Novel Biomaterials and High-end Medical Devices under the Guangzhou Market Supervision Administration, Guangzhou is exploring new application scenarios for patent data services in medical devices, creating a "dual-driven" model of "online + offline." Online, the service provides the "Zhi Miao Cloud" data platform, which accurately matches technical resources at both ends of the supply and demand chain. Enterprises can freely access core modules such as medical device patent search, innovative product approval, and industry data insights through the platform; AI-assisted generation of customized "Product Registration and Intellectual Property Layout Analysis Reports" reduces response time to 10 working days, significantly improving the efficiency of traditional manual analysis and providing data support for enterprises to precisely position themselves in the market and optimize R&D strategies. Offline, activities will be organized to accelerate the transformation of high-value patents, including industry-university-research matchmaking meetings, innovation achievement roadshows, and more, to promote the targeted penetration and value release of high-value patents in the industrial sector.

Recently, the Guangdong Provincial Medical Products Administration announced that, as of the end of December 2024, the "Hong Kong-Macao Medicine and Device Access" policy has successfully established a fast-track channel for innovative medicines and medical devices used in Hong Kong and Macao to enter clinical applications in mainland cities of the Guangdong-Hong Kong-Macao Greater Bay Area. There are 45 designated medical institutions and 97 varieties approved under this policy, including 49 types of medicines and 48 types of medical devices, benefiting nearly ten thousand residents of the Greater Bay Area. According to the "Hong Kong-Macao Medicine and Device Access" policy, designated medical institutions in the mainland part of the Greater Bay Area can use urgently needed medicines already on the market in Hong Kong and Macao, as well as advanced medical devices that have been procured by public hospitals in Hong Kong and Macao, following approval by Guangdong Province.

Recently, the General Office of the National Medical Products Administration issued "On Optimizing Lifecycle Supervision Measures to Support the Innovative Development of High-End Medical Devices (Draft for Comments)" Open for Public Comments. The draft proposes to strengthen standard-led innovation and further improve the standards system for high-end medical devices. Expedite the release of standards related to medical exoskeleton robots, radiopharmaceutical imaging equipment, and more. Accelerate the formulation and revision of basic, general standards and methodological standards in fields such as medical robotics, artificial intelligence medical devices, and advanced medical imaging equipment, while actively preparing to establish technical committees for standardization in medical robotics and AI-based medical devices. Enhance standardization research on new biomaterials like additive manufacturing medical materials, flexible electrodes for brain-computer interfaces, and genetically engineered synthetic biomaterials. Conduct research on digital standard datasets for AI-based medical devices. According to the needs of industrial development and regulatory requirements, urgently needed standards for high-end medical devices will be initiated through expedited procedures.

Recently, at the Brain-Computer Interface Innovation and Application Forum held during the 2025 Zhongguancun Forum Annual Meeting, Du Guangda, Deputy Director of the Science and Technology Department of the Ministry of Industry and Information Technology, stated that the rapid advancement of artificial intelligence technology is driving future-oriented intelligent technologies and products, such as brain-computer interfaces, to the eve of a boom. Going forward, the Ministry of Industry and Information Technology will strengthen top-level design, enhance collaboration with relevant departments, and release the "Guiding Opinions on Promoting the Innovative Development of the Brain-Computer Interface Industry." This will reinforce policy guidance at the national level, clarify industrial development goals and key tasks, adhere to demand-driven systematic planning, coordinate efforts comprehensively, and promote synergy among all parties to jointly advance the innovative development of the brain-computer interface industry.