中国医疗器械杂志最新文献

{"title":"[Integrated Innovation and Systematic Translation of Medical Devices].","authors":"Bo Xu","doi":"10.12455/j.issn.1671-7104.250382","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250382","url":null,"abstract":"<p><p>Against the backdrop of the deepening Healthy China strategy, the integrated innovation and systematic translation of medical devices have become pivotal pathways for enhancing healthcare service capabilities and overcoming critical technological bottlenecks. Addressing current challenges such as fragmented resources, inefficient collaboration, and translational barriers in medical device innovation, this paper establishes an integrated innovation mechanism centered on the deep convergence of \"medicine-research-industry-academia-application\", and designs a full-cycle systematic translation model spanning \"needs identification - R&D validation - regulatory approval - market application\". Through strategies including multi-stakeholder collaborative platform development, big-data and AI empowerment, and optimization of policy support systems, efficient allocation of innovation resources and dynamic optimization of translation processes are achieved. Case studies of United Imaging Healthcare and Mindray Medical confirm that integrated innovation significantly shortens R&D cycles and improves translation efficiency, offering a systematic solution to accelerate the domestication of high-end medical devices and strengthen global competitiveness.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"374-378"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867644","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Current Status and Challenges in the Regulation of Weight Management Medical Devices].","authors":"Yue Wang, Juan Yan, Xiao Jiang, Le Cui, Xiao Cao, Yue Wang, Chunqing Zhang, Jiong Zhu","doi":"10.12455/j.issn.1671-7104.250489","DOIUrl":"10.12455/j.issn.1671-7104.250489","url":null,"abstract":"<p><strong>Objective: </strong>With the global obesity crisis worsening and China launching the \"Weight Management Year\" initiative, demand for weight management medical devices has grown significantly. This study focuses on two key issues: the lack of a unified global classification framework for such devices and the fragmented understanding of international regulatory differences.</p><p><strong>Methods: </strong>From the technical perspective of medical device classification and determination, this paper reviews the regulatory landscape of such devices in the United States, Europe, Japan, South Korea, Australia, and Canada. Focusing on intragastric balloons, cryolipolysis devices, and medical-grade smart body fat scales, it compares classification approaches, restrictions on claims, and clinical validation requirements, while also analyzing controversies such as vague definitions and inconsistent risk assessments.</p><p><strong>Results: </strong>The analysis shows notable differences in regulatory philosophies across countries. The United States uses a model centered on risk and efficacy; the European Union emphasizes technical substantiation and full product lifecycle management; Japan and South Korea prioritize adaptability to local populations. A critical problem is the lack of unified core performance parameters: for example, the required fat reduction rate for cryolipolysis devices is ≥20% in the US but ≥15% in the EU, and there are no consistent thresholds for body fat measurement accuracy. This not only creates regulatory ambiguity but also leaves room for regulatory arbitrage. Overall, the global regulatory environment for weight management devices remains uncoordinated, facing challenges from vague definitions and inconsistent standards.</p><p><strong>Conclusion: </strong>Drawing on international experiences and China's specific regulatory context, this study proposes a framework for a China-specific regulatory system for weight management devices. Core recommendations include: refining technical and clinical standards for key products like medical-grade smart body fat scales; strengthening management of intended use claims to clarify regulatory boundaries; and establishing a closed-loop, full-lifecycle management system integrated with real-world data. These measures are expected to shift China's regulatory model from reactive response to proactive leadership, ultimately contributing to a \"Chinese solution\" to both high-quality industrial development and global regulatory harmonization.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"454-460"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Exploration of the Application of Blockchain in Medical Engineering].","authors":"Shiqiao He","doi":"10.12455/j.issn.1671-7104.250735","DOIUrl":"10.12455/j.issn.1671-7104.250735","url":null,"abstract":"<p><p>Blockchain technology, with its characteristics of decentralization, immutability, traceability, and high transparency, offers innovative solutions for the innovative development of the medical engineering field. As a key support for ensuring the quality, safety and efficiency of medical care, the medical engineering field is currently facing multiple challenges such as complex medical device management, severe data silos, opaque supply chains and prominent information security risks. This paper systematically summarizes the research status and development trends of blockchain in the medical engineering field. Firstly, it elaborates on the basic principles of blockchain technology and its high compatibility with the demands of medical engineering. Secondly, it focuses on three core dimensions: the full life cycle management of medical device, the security and sharing of medical device data, and the management of medical device and consumables supply chains, to deeply analyze the main application scenarios, key technologies, and existing research progress of blockchain. Thirdly, this paper discusses the typical architecture of medical engineering application systems based on blockchain and integrates and analyzes the empirical data on key performance indicators in existing research. Fourthly, this paper systematically summarizes the multi-dimensional challenges faced by the application of blockchain technology in the medical engineering field, including technical, regulatory, cost and organizational aspects, and conducts a comprehensive assessment of its feasibility. Finally, it looks forward to the future research directions in this field.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"407-414"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867664","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Development and Empirical Study of an FMEA-Based Risk Management Model for CBCT Equipment].","authors":"Jie Yang, Xiaomin Ren, Ronggao Tang","doi":"10.12455/j.issn.1671-7104.260020","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.260020","url":null,"abstract":"<p><strong>Objective: </strong>To construct a failure mode and effects analysis (FMEA) model for risk management of cone- beam computed tomography (CBCT) equipment and improve the level of equipment management.</p><p><strong>Methods: </strong>The lean management tool FMEA was used for full-process management evaluation. A total of 15 CBCT devices were selected, and four types of failure modes, including technical performance, environmental interference, system software, and operation norms, were identified. A total of 58 failure modes were confirmed, of which 10 were classified as high-risk effective interventions were carried out on the high-risk items, and a questionnaire survey was conducted to evaluate the effectiveness of the interventions.</p><p><strong>Results: </strong>The <math><msup><mi>χ</mi> <mn>2</mn></msup> </math> test and <i>t</i>-test were performed using SPSS 29.0. After the intervention, the mean risk priority number (RPN) for all four failure mode categories decreased significantly. The differences in both RPN values and work quality scores before and after the intervention were statistically significant.</p><p><strong>Conclusion: </strong>The FMEA model can be used for refined and scientific risk management of cone-beam CT equipment, effectively enhancing the operational capacity of medical equipment and improving the quality of clinical services.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"415-420"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867459","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Research on Exoskeleton Human-Machine Interaction for Walking Assistance in Myasthenia].","authors":"Xinhai Yin, Huaixian Li, Jiawei He, Lei Yang, Min Zhang","doi":"10.12455/j.issn.1671-7104.250593","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250593","url":null,"abstract":"<p><p>To address the insufficient human-machine interaction adaptability in current lower-limb rehabilitation exoskeletons, this study proposes a lower-limb assistive exoskeleton featuring active actuation at the hip and knee joints and passive following at the ankle joint. A rigid self-adaptive human-machine interface is adopted to provide both effective assistive torque and structural compliance, aiming to deliver gait assistance for individuals with muscle weakness while improving wearing comfort. First, a bionic geometric structure of the exoskeleton was constructed based on human lower-limb biomechanics, and passive degrees of freedom in the attachment components were designed using a serial-chain topology. The forward kinematics model of the exoskeleton was then established and verified using the D-H method. Finally, a human-exoskeleton coupled model was built on the OpenSim platform, in which the human model was configured to three muscle strength conditions (100%, 80% and 60% of the maximal isometric force). The assistive performance and interaction characteristics of the designed exoskeleton were evaluated through changes in two key indicators-overall metabolic consumption and human-robot interaction forces-as well as variations in hip and knee flexor-extensor muscle forces. The results show that the proposed exoskeleton effectively reduces human-machine interaction forces, with peak interaction forces at the thigh decreasing from 70 N to 20 N and those at the shank decreasing from 150 N to 30 N. The overall metabolic cost of the wearer was reduced by 13.8%-15.4%, and the muscle force outputs of major hip and knee muscle groups markedly decreased. These findings validate the rationality of the design and demonstrate its performance in adaptive human-machine interaction assistance, highlighting its application potential in rehabilitation training and gait assistance for individuals with muscle weakness.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"430-439"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867720","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Design and Implementation of a Dual-Mode Focused Ultrasound Treatment System].","authors":"Dan Chen, Weizhen Zhu, Zhehua Dong, Ke Li","doi":"10.12455/j.issn.1671-7104.250641","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250641","url":null,"abstract":"<p><p>This study presented the design, and preliminary validation of a dual-mode focused ultrasound system for thermal ablation and histotripsy based on a single transducer. The acoustic characteristic measurements indicated that the maximum acoustic power was approximately 185 W in thermal ablation mode and exceeded 6 000 W in histotripsy mode. Under different treatment parameters, the <i>ex vitro</i> experimental results demonstrated that the system could achieve coagulative necrosis through thermal ablation and liquefaction through histotripsy, which disintegrates tissue into homogenate, respectively. Therefore, this system can be used for preclinical research on the thermal and mechanical effects of focused ultrasound.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"440-446"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867104","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Research on Stability Evaluation Method for Key Performance of Clinical Mass Spectrometer Based on SPC].","authors":"Jiansong Xia, Ruobiao Li, Guofei Yan, Weidong Yang, Luyu Yao, Ningqing Chen, Hongqiang Jiang","doi":"10.12455/j.issn.1671-7104.250509","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250509","url":null,"abstract":"<p><p>As a Class Ⅱ medical device, clinical mass spectrometers face challenges in performance stability when operating in long-term, high-volume, and high-matrix clinical application scenarios. However, a unified standard method for evaluating performance stability has not yet been established domestically or internationally. This study aims to construct a scientific and universal evaluation system for the key performance stability of clinical mass spectrometers based on the statistical process control (SPC) theory, providing technical support for the access review of regulatory authorities and the quality improvement of manufacturing enterprises. Firstly, based on the division of clinical application needs and risk levels, key performance parameters such as detection limit and anti-interference capability, as well as their importance levels, are determined. Secondly, key performance data are collected by simulating actual clinical operating scenarios, and the X-bar-R control chart is used to judge the statistical steady state. Subsequently, the stability capability index (SCI) is developed with the process performance index (PP) as the core for technical steady-state evaluation. Finally, the stability levels are classified through the combined determination of statistical steady state and technical steady state. The effectiveness of the method is verified through the detection limit test using ICP-MS. The results show that this method can not only effectively evaluate the key performance stability of the instrument but also identify the root causes of instrument performance fluctuations. The conclusion indicates that the SPC-based method for evaluating the key performance stability of clinical mass spectrometers is scientific, operable, and economical. It can not only accurately predict the performance degradation trend of instruments and warn of failure risks but also provide a unified standard for the whole-life cycle quality control of medical devices. It is applicable to the stability evaluation of different types of clinical mass spectrometers and is of great significance for standardizing industry quality standards and improving clinical application safety.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"466-472"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867708","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Surveillance and Analysis of Events Related to the Extended Use of Active Medical Devices: an Empirical Study from the Post-Market Vigilance Perspective].","authors":"Jiahui Li","doi":"10.12455/j.issn.1671-7104.250653","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250653","url":null,"abstract":"<p><p>To examine how post-market vigilance can capture injury signals linked to prolonged use, individual adverse-event reports on active medical devices held by Shanghai Center for Adverse Drug and Medical Device Reaction Monitoring were screened. Reports explicitly mentioning \"prolonged/expired use\" were analyzed descriptively and key cases were dissected. Results show that 59.24% of all prolonged-use reports involved ten device types, led by electronic endoscopes, ECG equipment and dialysis machines. Common characteristics include complex architecture, non-replaceable or high-cost key components, and high software dependency. Case studies indicate that the use of high-frequency electrosurgical leads, high-pressure injection tubing, and electric suction units beyond their validated life-span directly precipitates events such as lead arcing, tubing burst, and suction failure, and is accompanied by systemic deficiencies of \"obsolete labeling and absent in-hospital maintenance strategies\". A post-market dynamic service-life assessment mechanism is proposed that integrates component-level life-cycle management, residual-risk communication, and timely instruction updating into a closed-loop governance framework.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"461-465"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867681","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Technical Exploration of Classification Management for Medical AI Large Models].","authors":"Xiao Jiang, Di Liu, Chenxi Wang, Yue Wang, Shankui Rong, Chunqing Zhang, Jiong Zhu","doi":"10.12455/j.issn.1671-7104.250774","DOIUrl":"10.12455/j.issn.1671-7104.250774","url":null,"abstract":"<p><p>The development and application of medical artificial intelligence (AI) large models in the medical field have brought opportunities and challenges to regulation. By reviewing the application and technical characteristics of AI large models in the medical field, starting from the perspective of medical device classification management, drawing on foreign regulatory experience, and based on China's regulatory reality, the technical characteristics of medical AI large models are analyzed. Provide suggestions for defining attributes and categorizing AI large models, and offer reference for their technical classification management.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"447-453"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867712","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"[Particle Arc Therapy (PAT): Technical Advances and Clinical Application Prospects].","authors":"Xiaowa Wang, Weiming Sun","doi":"10.12455/j.issn.1671-7104.250559","DOIUrl":"10.12455/j.issn.1671-7104.250559","url":null,"abstract":"<p><p>Particle Arc Therapy (PAT) represents a cutting-edge innovation in modern radiation therapy, encompassing two principal modalities: Spot-Scanning Proton Arc Therapy (SPArc) and Spot-Scanning Heavy Ion Arc Therapy (SHArc). By delivering beams continuously along an arc trajectory, PAT enables highly conformal dose distributions and improved sparing of organs at risk (OAR), particularly in complex anatomical sites. Existing studies have demonstrated that, compared with conventional Intensity-Modulated Proton Therapy (IMPT), SPArc can reduce the mean OAR dose by approximately 10%-20% ( <i>P</i><0.05), while achieving enhanced plan robustness and delivery efficiency. SHArc, benefiting from the high Linear Energy Transfer (LET) characteristics of heavy ions, is theoretically advantageous for the treatment of radioresistant tumors. This review provides a comprehensive overview of the physical and technical foundations of PAT, its planning optimization strategies, and recent clinical and preclinical developments. Challenges related to robustness verification, motion management, and cost-effectiveness are also discussed. Overall, PAT-particularly SPArc-exhibits promising translational potential and is poised to become an important direction in the future of precision radiotherapy.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"391-399"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867738","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}