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Globus Medical Launches ExcelsiusHub Navigation System

On December 2, GE HealthCare announced the acquisition of the remaining 50% stake in Nihon Medi-Physics (NMP) from Sumitomo Chemical, to gain full ownership of this Japanese radiopharmaceutical company, NMP. According to an announcement by Sumitomo Chemical, this transaction is expected to increase its operating income by approximately 30 billion yen (about 1.455 billion yuan). Established in 1973 and headquartered in Tokyo, Japan, NMP was originally a joint venture between British life sciences company Amersham and Sumitomo Chemical. In 2004, GE Healthcare acquired a 50% stake in NMP through its purchase of Amersham and secured three seats on the board of directors. NMP’s main business areas include research, production, sales, procurement, and import/export of radiopharmaceuticals, as well as radioactive medical devices and related products. Its product portfolio is divided into two major categories: diagnostic (SPECT and PET) and therapeutic (radioactive medical devices and radiopharmaceuticals).

Recently, Suzhou Yimuwansiang Technology Co., Ltd. (hereinafter referred to as "Wansiang Technology") joined hands with Beijing Tinavi Medical Technologies Co., Ltd. (hereinafter referred to as "Tinavi"), to engage in in-depth exchanges and explore deep cooperation regarding their core products — the "WIL Meta® Yuanxiang Series 3D C-arm Machine" and the "TiRobot® Orthopedic Surgery Robot." The highlight of this collaboration between Wansiang Technology and Tinavi is that through a series of rigorous system tests and experiments, they successfully crossed industry boundaries in a very short time, achieving seamless integration and interconnectivity between the WIL Meta® Yuanxiang Series 3D C-arm Machine and the TiRobot® Orthopedic Surgery Robot. The interoperability and synergy of the two products achieved "1+1>2," not only improving surgical efficiency and enhancing surgical safety but also increasing the accessibility of intraoperative imaging and overall robotic surgery solutions, benefiting a broader population. This collaborative working model provides orthopedic surgery patients with safer, more efficient, precise, and accessible surgical treatment options.

Recently, the General Office of the Hubei Provincial Government released the "Implementation Opinions of the General Office of the Provincial People's Government on Accelerating the High-Quality Development of the Biomedical Industry." The Opinions propose 22 measures to accelerate the development of the biomedical industry. Among them, the proposed goal is that by 2027, the revenue of Hubei Province's biomedical industry will double, reaching 250 billion yuan; cultivating one enterprise with revenue exceeding 50 billion yuan, 35 enterprises exceeding 10 billion yuan, and eight enterprises exceeding five billion yuan. In the field of medical devices, efforts will be made to expedite the industrialization and promotion of high-end medical equipment such as advanced medical imaging devices, surgical robots, integrated digital operating rooms, minimally invasive myocardial excision systems, digital navigation tools, as well as high-value consumables like implantable artificial joints and 3D-printed spinal products, fostering five major product categories each worth 1 billion yuan.

Recently, the Hainan Provincial Drug Administration revised the "Detailed Rules for the Implementation of Medical Device Operation Supervision and Management in Hainan Province (Draft for Comments)" and once again solicited public opinions. The draft applies to the operation of medical devices and their supervision and management within the administrative region of Hainan Province. The draft specifies that enterprises engaging in the operation of Class III medical devices must apply for an operation license from the drug administration department at the county or city level where they are located, and submit relevant materials according to the application requirements published on the Hainan Provincial Government Service Network to handle matters related to the issuance, renewal, modification, reissue, and cancellation of medical device operation licenses. Enterprises engaging in the operation of Class II medical devices must register with the drug administration department at the county or city level where they are located and submit relevant materials according to the application requirements published on the Hainan Provincial Government Service Network to handle registration matters. Enterprises solely operating Class II medical devices listed in the "List of Class II Medical Device Products Exempt from Operation Registration" issued by the National Medical Products Administration are exempt from operation registration.

Recently, the Beijing Municipal Medical Products Administration released the "Technical Review Guidelines for Standalone Software of Class II Medical Devices," which applies to the registration application of standalone software. In the "Medical Device Classification Catalog," the classification code is 21 for medical software. The key technical review points specified in the "Guidelines" include: product name, product structure and composition, intended use of the product, product working principle, product risk management documentation, product technical requirements, software research, product instructions and label drafts, and product changes.

In recent years, the Tianjin Municipal Drug Administration has adhered to the "four strictest" requirements as the fundamental guideline, exploring the path of "building platforms, creating ecosystems, gathering industries, and promoting development." It has transformed the blueprint for high-quality development into a "construction plan" and turned it into a "real-life picture," assisting in the high-quality development of the biopharmaceutical industry. First, it meticulously cultivates the "real-life picture" of "inheritance and innovation revival of traditional Chinese medicine," supporting the construction of Tianjin as a strong city in traditional Chinese medicine. Second, it meticulously cultivates the "real-life picture" of "incubation and transformation of innovative drugs," promoting the accelerated development of new productive forces. Third, it meticulously cultivates the "real-life picture" of "innovative leadership in high-end medical devices," building an origin, transformer, and ecosystem for the medical device industry. Upholding the concept of "co-building ecosystems and promoting development together," it collaborates with the Chinese Society of Biomedical Engineering, the China Association for Medical Devices Industry, and the Dongli District Government to establish the Tianjin High-End Medical Device Innovation Research Institute. Fourth, it meticulously cultivates the "real-life picture" of "Jinggu's beauty industry sharing and improvement," promoting strong alliances and complementary advantages among cosmetics companies.

Recently, four local regulations in Guangdong Province and the three cities of Zhuhai, Heyuan, and Dongguan have come into effect. The contents cover the import of Hong Kong and Macao medicines and medical devices, prevention and control of environmental pollution by solid waste, promotion of talent development, and protection of intangible cultural heritage. To advance the implementation of the "Hong Kong-Macao Medicine and Device Access" policy and ensure the safety and needs of medicine and device use for residents of the Guangdong-Hong Kong-Macao Greater Bay Area, the "Regulation on the Administration of Importing Hong Kong and Macao Medicines and Medical Devices in the Nine Mainland Cities of the Guangdong-Hong Kong-Macao Greater Bay Area" focuses on multiple aspects such as application, procurement, importation, distribution, and usage to streamline and optimize the entire chain management. For instance, the regulation improves the review and customs clearance management for urgently needed Hong Kong and Macao medicines and devices, addressing issues like lengthy application and review processes in actual implementation. It reduces the review period for applications to import and use medicines and medical devices listed in the urgent Hong Kong-Macao medicine and device catalog to "5 working days + 5 working days," and compresses the review period for applications to import and use items outside the catalog to "10 working days + 10 working days."

Recently, the National Institutes for Food and Drug Control (NIFDC) released the "Public Notice on the Instructions for 6 In Vitro Diagnostic Reagent Reference Materials Including ABO Blood Group Genotyping National Reference Material." Specifically, these include: 1. Instructions for ABO Blood Group Genotyping National Reference Material; 2. Instructions for Valproic Acid, Phenytoin, and Phenobarbital Frozen Human Serum National Standard; 3. Instructions for Streptococcus Pneumoniae Nucleic Acid Detection Reagent National Standard; 4. Instructions for Hepatitis B Virus (Type A) Nucleic Acid National Standard; 5. Instructions for Helicobacter Pylori Antigen Detection Reagent National Reference Material; 6. Instructions for NTRK Gene Fusion Mutation Detection National Reference Material.

Recently, the Chongqing Medical Science and Technology Innovation Achievement Transformation Competition was successfully completed. At the award ceremony of the competition, the Chongqing Medical Intellectual Property Operation Center was officially inaugurated. The center is located at the National Vocational Skills Appraisal Institute under the Chongqing Municipal Health Commission. After its establishment, the Chongqing Medical Intellectual Property Operation Center will strengthen the creation, protection, and application of medical intellectual property, improve the effectiveness of medical science and technology achievement transformation, and promote high-quality and innovative development of healthcare in Chongqing. During the Chongqing Medical Science and Technology Innovation Achievement Transformation Competition, multiple medical innovations closely related to everyday life were showcased. The "Intelligent Gait Overall Solution," which won the first prize in the equipment category, innovatively addresses gait issues among the public. It captures dynamic gait indices and static foot characteristics non-invasively and without radiation. After the patient's 3D foot model is algorithmically analyzed, it can directly match with a database of 3D auxiliary device models and instruct a 3D printer to customize personalized aids.

Recently, the National Medical Products Administration approved the registration applications for two innovative products: "Implantable Cardiac Pacemaker Leads" from Chuangling Heart Rhythm Management Medical Devices (Shanghai) Co., Ltd. (referred to as: Chuangling Heart Rhythm Medical) and "Zirconia Ceramic Femoral Heads" from Beijing Ansong Technology Co., Ltd. (referred to as: Ansong Technology).