Weekly Medical Device News Roundup (Nov 24–30, 2025): Funding, Approvals, and Global Launches

Dec 02, 2025 08:01 CST Updated 08:01

Shoulder Innovations

Shoulder Replacement System Developer

Primed Medical receives investments from Huatai Zijin and othersB+ Round Investment

Recently, Nanjing Pulimeng Medical Technology Co., Ltd. announced the completion of its B+ round of financing. This round of financing was jointly participated by Huatai Zijin Investment and Xingong Industrial Investment, with the specific amount not disclosed. Pulimeng, established on March 23, 2016, is a technology company focusing on medical device research and development. It mainly dedicates itself to the R&D, production, and sales of sutures, with product lines including absorbable synthetic surgical sutures, knotless absorbable sutures, non-absorbable surgical sutures, and self-sealing non-absorbable surgical sutures. With the core mission of providing modern medical products and services, Pulimeng is committed to driving technological innovation and upgrading in the medical industry. The completion of this B+ round of financing will further accelerate Pulimeng's R&D progress in the suture field and provide strong financial support for its market expansion.

Chinese Leading Medical Device Company Receives Strategic Investment from State-Owned Capital

Recently, MicroPort Medical Science and Technology Co., Ltd. announced that Shanghai BioPharmaceutical M&A Fund under Shanghai Industrial Investment Corporation Capital intends to acquire the shares of MicroPort Medical held by Otsuka Medical Devices Co., Ltd. through a contractual transfer, becoming a strategic shareholder of MicroPort Medical. This marks that the M&A Fund, as a professional operation platform with state-owned capital background, is playing an active role in precisely empowering, stabilizing development, and reshaping value for local biopharmaceutical "chain leader" enterprises. MicroPort Medical is an innovative high-end medical device leading enterprise and core "chain leader" enterprise cultivated and grown locally in China, which has gone global. Its stable development plays a crucial role in the high-end medical device industry chain both in China and globally. This transaction, with capital as the link, provides key support to domestic "chain leader" enterprises, maintaining the stability and development of their core assets. Through this transaction, the M&A Fund will inject momentum into its higher-quality and sustainable development in multiple dimensions and comprehensively.

Aifang Biotech Completes Multi-Million Yuan Angel Round Financing

Recently, Hunan Aifang Biotechnology Co., Ltd. successfully secured tens of millions of yuan in angel round equity financing, with Xiangxiang Capital as the investor. This round of equity financing will inject strong momentum into Aifang Biotech’s efforts in product development, market expansion, and team building. Founded in 2020, Hunan Aifang Biotechnology Co., Ltd. is located in Changsha's Xiangjiang New Area. It is a national high-tech enterprise, a specialized and innovative small and medium-sized enterprise, and a pilot intelligent manufacturing enterprise in Changsha. The company integrates R&D, production, and sales of tumor pathology diagnostic reagents. It owns over 7,000 square meters of R&D and production laboratories, holds 20 authorized patents, and has multiple invention patents currently under application. Its main projects include an mIHC multiplex fluorescence staining & advanced AI data analysis integrated solution, and immunohistochemistry for clinical pathology diagnosis.

Medical Device Unicorn Plans to Raise Funds700 million

Recently, Shoulder Innovations, an innovative medical technology company, submitted its IPO prospectus to the U.S. Securities and Exchange Commission (SEC) for a planned listing on Nasdaq under the ticker symbol "SHLD," with a preliminary fundraising target of $100 million (approximately 700 million RMB). This public offering will provide capital support to expand its product portfolio and accelerate the integration of AI with surgical ecosystems, while also bringing its technology focused on solving the clinical challenge of "glenoid loosening" into broader market visibility. Regarding the use of proceeds, the company plans to allocate the IPO funds primarily toward three key areas: launching a revision system and fracture-specific implants to broaden procedural coverage; enhancing the development of AI tools and the integration of surgical navigation systems; and expanding the sales team and overseas market access, including EU CE certification and strategic expansion in the Asia-Pacific region. This indicates that Shoulder Innovations will extend its existing glenoid technology platform to address more medical conditions and market scenarios.

Yahuilong Obtains Certification for New Autoimmune Instrument

Recently, the fully automatic fluorescence immunoassay analyzer (Guangdong Medical Device Registration No. 20252221513) independently developed by YHLO has been approved by the Guangdong Provincial Drug Administration for medical device registration. Based on the principle of liquid-phase chip technology, this multi-test platform is mainly used for autoantibody detection, expanding YHLO's autoantibody detection platform and enriching market diversity. Utilizing liquid-phase chip technology, it forms thousands of black-and-white striped magnetic barcode chips through a specific process to achieve multi-assay testing. The equipment features three main highlights: a single unit occupies only 0.8m², supports 2-4 units for cascading expansion, and offers a testing throughput of up to 4896 tests per hour to meet various customer needs; the antinuclear antibody panel includes a small combination of seven items; it can be connected with YHLO’s chemiluminescence platform and assembly line to jointly build a smart laboratory.

"Chengdu-Made" Five-Arm Surgical Robot Successfully Completes Animal Trials

Recently, the animal experiment of the five-arm laparoscopic surgical robot developed by Nuofutai Intelligent Technology Company in Chengdu Tianfu International Bio City was successfully completed. Professor Xu Li's team from China-Japan Friendship Hospital used the robot to precisely perform a combined liver and gallbladder resection on experimental animals. This robot is a gasless abdominal real-time force feedback five-arm dual-control laparoscopic surgical robot. It features an innovative serial-parallel hybrid mechanical arm design, capable of simulating the flexible movements of the human wrist, with endpoint operation precision reaching millimeter-level, paired with high-definition imaging.3D vision that filters out hand tremors of the surgeon; innovative realization of synchronized operation with dual consoles and five robotic arms, significantly improving surgical efficiency and reconstructing the clinical teaching model; adoption of a rigid transmission system. This experiment successfully validated its feasibility in complex hepato-biliary combined surgeries.

VINNO"Sound, Light, and Air" Combine Forces, Endoscopic Series Makes Global Debut

On November 26, 2025, it was reported that Vinno showcased a groundbreaking new solution at MEDICA 2025, stemming from its self-driven innovation. A refreshed vision, beyond just sound. Beyond the dazzling array of ultrasound products, Vinno has embarked on two new ventures: the Vicyto endoscope series and the Stream sleep ventilator, forming an innovative integration of "sound, light, and air" to power the ever-evolving pursuit of health. At the exhibition, numerous experts expressed admiration for the micron-level imaging delivered by URM super-resolution microscopy. Since its launch, URM has been continuously unleashing its potential on the international stage. In Europe, Vinno has partnered with leading medical institutions such as University Hospital Erlangen in Germany to apply URM super-resolution microscopy technology in research exploring adult kidney transplantation, revealing the morphological structure and blood flow of microscopic vessels in transplanted kidneys.Flow dynamics assist doctors in earlier identification of potential lesions or rejection reactions in transplanted kidneys, safeguarding the patient's postoperative recovery process from the source.

Precision Edge® Robot's Debut in Germany via Remote Operation

Recently, the 15th German Robotic Urology Symposium (DRUS 2025) concluded in Hamburg, with Chinese innovation taking center stage. The Jingfeng® Multi-Port Endoscopic Surgical Robot was officially launched in Germany, stunning the audience with a super remote surgery demonstration spanning 8,100 kilometers across Europe and Asia. Professor Chen Lingwu from the First Affiliated Hospital of Sun Yat-sen University operated the Jingfeng robot to perform a remote radical prostatectomy. The surgery achieved an ultra-low bidirectional latency of just 125 milliseconds, with clear anatomical layers and minimal bleeding, earning widespread acclaim from European peers. Professor Chen Lingwu stated that the key to China's urology field transitioning from "catching up" to "leading" lies in the maturity of hands-on practice and remote technology. Conference Chair Professor Christian Wülfing highly praised the stability, precision, and meticulousness of the surgery, noting the astonishing development speed of Chinese surgical robots, with Jingfeng’s technology now at the world's forefront. Additionally, Professor Zhang Shudong demonstrated a partial nephrectomy using the Jingfeng robot.

MindrayIVD Unleashes Major Moves

Recently, the "Qiyuan Laboratory Large Model," a large model in the vertical field of clinical laboratory testing, was released at the Southern Laboratory Medicine Academic Conference. This model was co-developed by Mindray and Southern Medical University Shenzhen Hospital, among others, with support from multiple departments in Shenzhen. Unlike general large models, it builds expert thinking through a four-stage progressive approach: "professional learning - clinical training - cognitive simulation - continuous evolution." Professional learning establishes the knowledge base, clinical training refines expert thinking, cognitive simulation achieves evidence-based reasoning, enhancing clinicians' trust in AI decision-making, thereby completing the iterative loop for clinical application. Currently, the intelligent report review and interpretation function of the "Qiyuan Laboratory Large Model" has been implemented at Southern Medical University Shenzhen Hospital and deployed at the Cancer Hospital affiliated with Guangzhou Medical University, capable of integrating multidimensional information to comprehensively analyze complex reports.

Rui Ci Medical Group and United Imaging Group Reach Strategic Cooperation

On November 21, Rich Healthcare Group and United Imaging Group signed a strategic cooperation agreement. United Imaging's AI technology and equipment will be integrated into Rich Healthcare’s high-end health checkup and clinical diagnosis systems. With 25 years of experience in healthcare, Rich has built a nationwide medical service network across China. The collaboration fully covers Rich Healthcare’s core businesses, focusing on two key empowerment approaches: introducing high-end imaging equipment integrated with AI to achieve full-process intelligence, and leveraging large-scale medical models to enhance precise screening and efficient diagnosis. Both parties are also committed to creating a closed-loop system for integrated health management and medical services. They will jointly establish the first "Joint Innovation Center for Artificial Intelligence Ultrasound Applications" in the non-public healthcare sector to address challenges in ultrasound examinations and promote standardization, intelligence, and accessibility. This partnership goes beyond cooperation on single imaging equipment; in the future, the two sides will engage in in-depth exchanges across multiple fields, co-create new equipment applications and clinical service models, and explore further possibilities in the integration of technology and healthcare.

Zhongguancun Simoon HealthcareCMA "Passive Medical Devices" Field Expansion Review Approved, Qualification and Capability Upgraded Again

Beijing Zhongguancun Shuimu Medical Technology Co., Ltd. Successfully Passes the PassiveCMA Expansion Review: Qualification and Capability Upgrade Approved for 45 Standards and 209 Items, Covering Physics, Microbiology, and Chemical Testing. This includes numerous sub-items such as body seal integrity, sterility, and ethylene oxide residue. To ensure accurate and reliable test data, the company has introduced more than 50 advanced equipment sets, including gas chromatographs, and conducts strict calibration and maintenance. Its passive testing applies to sterile accessory testing of various devices, including infusion devices, implantable and interventional devices, endoscopic devices, and active medical devices. ZGC Shuimu Medical, established in 2017, is China’s first privately-owned third-party professional medical device inspection agency. The company has nearly 4,000 square meters of laboratory space for testing, a mature and robust inspection team, and is committed to providing the industry with comprehensive, professional, and rapid inspection services.

Publication of Sichuan Province's Innovative Pharmaceutical and Medical Device Product Directory

Recently, the 2025 Sichuan Province Innovative Pharmaceutical and Medical Device Supply and Demand Matching Event was held in Chengdu. The event released the Sichuan Province Innovative Pharmaceutical and Medical Device Product Catalog, which includes 10 innovative drugs (such as Recombinant Human Interleukin-2 Injection) and 33 innovative medical devices (such as Cardiac Pulsed Field Ablation System). The Sichuan Provincial Healthcare Security Bureau and the Sichuan Provincial Health Commission respectively interpreted policies supporting the development of innovative pharmaceuticals and medical devices. In recent years, Sichuan has continuously promoted the development of innovative pharmaceuticals and medical devices, forming a full-cycle policy loop. It has been approved for several national medical centers and regional medical center construction projects, providing clinical support for the implementation of innovative achievements. To accelerate the entry of innovative pharmaceuticals and medical devices into hospitals, medical institutions at all levels are required to establish a "green channel" for entry. Within one month after the release of the new preferred pharmaceutical and medical device catalog, a pharmaceutical affairs meeting should be convened, ensuring procurement within two months for urgently needed products with significant value. The Provincial Health Commission will also continue to host relevant activities to support the creation of application demonstration scenarios.

Liaoning Provincial Drug Administration Revises the "Priority Registration Procedure for Class II Medical Devices in Liaoning Province"

Recently, the Liaoning Provincial Drug Administration revised and released the "Priority Registration Procedure for Class II Medical Devices in Liaoning Province," which took effect upon issuance. This revision focuses on adjusting the applicable scenarios and submission materials of the original procedure to further enhance its applicability and relevance. First, Class II medical devices in high-end medical equipment such as medical robots, brain-computer interface devices, advanced medical imaging equipment, innovative traditional Chinese medicine diagnostic and treatment devices, artificial intelligence medical devices, and new biomaterial medical devices have been included in the priority registration scenarios. Second, situations like "being included in national or provincial major science and technology projects or key R&D plans, and legally owning core product technology patents in China" from the original procedure have been incorporated into the special review process for innovative Class II medical devices in Liaoning Province. Third, specific requirements for corresponding submission materials have been adjusted.

Zhejiang Deepens Reform in Drug and Medical Device Regulation

Recently, the Zhejiang Provincial Drug Administration and othersSeven Departments Issue the "Implementation Opinions on Comprehensively Deepening the Reform of Drug and Medical Device Regulation to Promote High-Quality Development of the Pharmaceutical Industry in Zhejiang Province," Effective from November 27. The Opinions focus on five aspects, proposing 20 specific recommendations aimed at addressing bottlenecks in the biopharmaceutical industry chain and promoting high-quality industrial development. Zhejiang's pharmaceutical industry still needs to enhance its capabilities and innovation capacity. Based on the challenges faced by the industry, the Opinions aim to resolve pressing difficulties for enterprises, such as the lack of high-level innovation platforms and clinical research resources for pharmaceutical innovation, by proposing measures like upgrading scientific and technological innovation support. According to the requirements of the Opinions, by 2027, Zhejiang's drug regulatory system will be more comprehensive, and by 2035, capabilities such as scientific drug regulation will reach international standards.Taking the lead, basically achieving the modernization of provincial drug regulation.

Anhui Provincial Drug AdministrationElectronic Certificates for Enterprises to be Enabled on August 1

Recently, the Anhui Provincial Drug Administration issued the "Announcement on the Activation of the First Batch of Electronic Licenses," clarifying that starting from August 1, 2025, the first batch of eight electronic licenses related to administrative approval for enterprises will be officially activated. This move aims to "reduce the burden and accelerate processes" for enterprises through digital reform, further enhancing the efficiency of government services in the field of drug regulation. The announcement stipulates that the licenses included in electronic management involve eight administrative approval items: drug production, drug distribution, medical device production, cosmetic production, medical institution preparations, as well as the production, distribution, and use of radioactive drugs. The electronic licenses include the main copy, duplicate, appendix, and change record pages, covering all approval information after August 1, 2025, achieving full-process digital recording and management of approval matters.

Shanghai Issues New Policies to Promote High-Quality Development of the Medical Device Industry

Recently, the General Office of the Shanghai Municipal People's Government released the "Several Measures for the Comprehensive Deepening of Drug and Medical Device Regulatory Reforms to Promote High-Quality Development of the Pharmaceutical Industry in Shanghai," explicitly expanding the scope of medical insurance payments for medical service items and medical consumables to cover more innovative products. It requires that within one month after the release of the national medical insurance catalog or the "New and Excellent Drugs and Devices" catalog, medical institutions promptly equip and use them according to clinical needs. For Class II medical devices with significant clinical value and strong innovation, Shanghai encourages the application for the Innovative Special Review Process, prioritizing registration inspection, technical evaluation, and system verification; products that are the first of their kind in China or meet the priority approval criteria will be treated accordingly. At the same time, pre-application counseling and in-process service mechanisms will be optimized to improve application quality and shorten correction cycles, with the goal of reducing the average cycle for the initial registration of Class II medical devices to six months.

Changping Life Valley (International) Bioengineering Innovation Center Launches

Recently, the Life Valley (International) Biotechnology Conference, themed "Intelligent Mapping of Life, Leading the Future,"Launch Ceremony of Cheng Innovation Center Held. At the ceremony, the attending leaders and guests jointly launched the innovation center. Fifteen cutting-edge enterprises signed agreements as resident companies, relevant partner institutions conducted fund signings to establish a "industry + capital" dual-driven model, and the "Innovation Zhuang Coffee" brand was also unveiled on site. The Life Valley (International) Bioengineering Innovation Center will focus on multiple advanced fields, forming a full life-cycle ecological closed loop, becoming a highland for innovation breakthroughs and achievement transformations. Additionally, the 2025 Beijing·"Life Valley" Intelligent Empowerment of Life Sciences and Health Seminar was held on the same day, where experts focused on the topic of "Intelligent Empowerment in Life Sciences and Health," sharing insights. Representatives from universities and research institutes attended.

Beijing Implements 15 Measures to Establish a Medical Device Industry Hub

Recently, the Beijing Municipal Bureau of Economy and Information Technology and five other departments jointly issued the "Several Measures of Beijing Municipality to Promote the High-Quality Development of the Medical Device Industry." This policy has been implemented sinceImplemented from November 24, 2025, and valid until December 31, 2028. Among these, the "Measures" have pressed the "accelerator" for "AI + Healthcare." Medical institutions are encouraged to refer to existing artificial intelligence medical service price items to incorporate new AI-assisted diagnostic technologies into use. The "Measures" encourage enterprises, research institutions, and medical institutions to form cross-disciplinary innovation consortia in medicine and engineering. By implementing the Capital Medical Science and Technology Innovation Achievement Transformation Promotion Plan and the "Create to Win the Future" project open roadshow, they aim to drive the implementation of forward-looking innovative achievements. In terms of approval speed, addressing the pain point of "slow market entry" for urgently needed clinical devices, it clearly stipulates immediate receipt and inspection for passive medical devices.The inspection time limit for in vitro diagnostic reagents has been reduced to an average of 60 working days, and the inspection time limit for active medical devices has been compressed to an average of 90 working days.

MIIT Launches the Creation of National Emerging Industry Development Base

Recently, according to"MIIT Micro News" WeChat Official Account reported that the Ministry of Industry and Information Technology has issued a notice to launch the creation of National Emerging Industry Development Demonstration Bases (hereinafter referred to as Demonstration Bases). The Demonstration Bases include two types: parks and enterprises. Park-type Demonstration Bases will focus on promoting industrial cluster development, collaborative innovation, ecological optimization, and governance enhancement, while enterprise-type Demonstration Bases will strengthen exploration in product development, technological innovation, business model innovation, and management efficiency. By 2035, around 100 park-type Demonstration Bases and about 1,000 enterprise-type Demonstration Bases will be established, forming a group of core forces and important engines leading the development of emerging industries, and summarizing and promoting a batch of experiences for growth and expansion.Effective experience and practices in promoting industrial development provide strong support for fostering new drivers and advantages of economic development and advancing new industrialization.

Notice on Publicly Soliciting Opinions for the "Guiding Principles for Registration Review of Joint Replacement Surgery Navigation and Positioning Systems (Draft for Comments)"

To guide the development of navigation and positioning systems for joint replacement surgeries and the preparation of registration application materials, and to ensure proper technical evaluation, a certain center drafted the "Guiding Principles for Registration Review of Navigation and Positioning Systems for Joint Replacement Surgeries (Draft for Public Comment)" and has solicited public opinions. Relevant personnel in the field are required to fill out the feedback form and send it to the designated email address before December 10, 2025. These guiding principles aim to assist registration applicants in preparing the necessary registration documentation and also serve as a reference for review departments. They represent general requirements for product registration submissions, do not involve administrative matters, are not legally mandatory, and can be used under the premise of compliance with relevant regulations and standards. They will be appropriately adjusted with updates to regulations, standards, and technological advancements. The guiding principles apply to navigation and positioning systems and navigation systems that assist doctors in performing joint replacement surgeries; other similar medical device products may refer to them accordingly. Products intended for use in other hard tissue surgical fields are outside their scope. Requirements for product naming and other regulatory information are also specified.

Guidance Principles for the Registration Review of Elbow Joint Prosthesis Systems: Solicitation of Opinions

The Chinese National Medical Products Administration (NMPA) has organized the drafting of seven medical device registration review guidelines, including the "Draft Guideline for Registration Review of Light-Cured Calcium Hydroxide Pulp Capping Agents," based on the 2025 annual revision plan for medical device registration review guidelines. These cover multiple fields such as dentistry, craniomaxillofacial, bone filling, and joint prostheses. The registration review guideline for elbow joint prosthesis systems is currently open for public comment. The drafts are now available online for public feedback. If any organizations have comments or suggestions, they must fill out a feedback form and send it via email to the respective contact person by December 21, 2025. Both the email subject and file name must follow a designated format. The document also lists the contacts and their information for each guideline.

Note: The information in this article is compiled based on online news.

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