中国医疗器械杂志最新文献

{"title":"[Progress and Prospects of Ultrasound Brain-Computer Interface Medical Devices Technology].","authors":"Qianwen Huang, Xun Liu, Xiang Ji, Ruonan Jin, Chang Liu, Kaixiang Jin, Sheng Hu","doi":"10.12455/j.issn.1671-7104.250652","DOIUrl":"10.12455/j.issn.1671-7104.250652","url":null,"abstract":"<p><p>Brain-computer interface (BCI) medical devices represent a category of innovative medical devices. They assist in treating neurological disorders by leveraging human-machine interaction to improve patients' quality of life. Simultaneously, ultrasound is a non-invasive and effective medical physics technology. It enables imaging of cerebral hemodynamic changes and neuromodulation, specifically for acquiring brain activity information and stimulating deep brain tissues. Notably, ultrasound BCI medical devices targeting deep brain stimulation remain in the research and clinical trial phases. Consequently, ultrasound BCI technology has significant research prospects. In this paper, different types of ultrasound BCI medical device technologies are firstly summarized and organized, followed by a review of their current research status. Then, the regulatory laws and regulations for ultrasound-based BCI devices are briefly discussed, and finally the future regulatory requirements for related products are prospected.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"181-187"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693723","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 Application of Multi-RevRobot for the Translation of Clinical Evidence of Traditional Chinese Medicine].","authors":"Zhaochen Ji, Haiyin Hu, Zhiyuan He, Yazi Zhang, Xiaolei Wu, Zifan Sang, Jing Hu, Zhe Wang, Yunhua Xue, Junhua Zhang","doi":"10.12455/j.issn.1671-7104.250372","DOIUrl":"10.12455/j.issn.1671-7104.250372","url":null,"abstract":"<p><strong>Objective: </strong>Under the background of policy guidance and technological development, the Multi-RevRobot for the translation of clinical evidence of traditional Chinese medicine (TCM) was developed to enhance the efficiency and applicability of clinical evidence translation in TCM.</p><p><strong>Methods: </strong>A prototype of Multi-RevRobot was designed and developed. This involved components such as the perception system, control system, execution system, power system, and interaction system. Universal model interfaces were integrated to connect with vertical large models and knowledge bases, enabling intelligent interaction. The artificial potential field method was combined with reinforcement learning to achieve efficient coordination between the robot's global path planning and local obstacle-avoidance decision-making. This allows the robot to be deployed and applied in various scenarios.</p><p><strong>Results: </strong>Multi-RevRobot features intelligent interaction, report generation, and multi-scenario adaptability. It provides a practical solution for TCM clinical evidence translation and plays corresponding roles in various scenarios.</p><p><strong>Conclusion: </strong>Multi-RevRobot is expected to serve as a clinical and research assistant for doctors, researchers, patients, and other groups. It can improve the efficiency of TCM-related work and facilitate the intelligent and efficient translation and application of TCM evidence.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"119-128"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693574","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 Standards and Development Trends for Injectable Dermal Fillers].","authors":"Senju Ma, Jun Peng, Siying Zeng, Shuhan Wang","doi":"10.12455/j.issn.1671-7104.250440","DOIUrl":"10.12455/j.issn.1671-7104.250440","url":null,"abstract":"<p><p>With the rapid development of the medical aesthetics industry, new filling materials and new technologies and products are constantly being innovated, providing consumers with more diverse choices. However, behind the rapid development of the industry, issues such as product safety, the persistence of efficacy, and long-term health risks have gradually emerged. The current standard system still has obvious deficiencies. The update speed of standards lags behind that of new materials and new technologies, resulting in the lack of targeted regulations for many innovative products. Therefore, this article provides an overview of the current status of standards for injectable dermal fillers, the deficiencies of the standards, and the research directions of future standards, with the aim of providing a reference for the standardized development and clinical application of injectable dermal fillers in the field of medical aesthetics.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"225-230"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693712","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":"[Evaluation of Body Surface Wound Absorption for Medical Dressings].","authors":"Chongfa Lai, Li Li","doi":"10.12455/j.issn.1671-7104.250500","DOIUrl":"10.12455/j.issn.1671-7104.250500","url":null,"abstract":"<p><p>Body surface wound test is a key method for evaluating the transdermal absorption behavior of active ingredients in medical devices. It can provide information on the degree, rate, and pathway of transdermal absorption of medical devices or their extracts, offering important supportive evidence for assessing the safety and effectiveness of medical devices. The body surface wound absorption test is suitable for medical dressing devices that come into direct contact with wounds. With the rapid development of new dressing products such as recombinant collagen in China in recent years, the evaluation of body surface wound absorption plays an important role in the preclinical evaluation of medical dressing products. This review systematically explores the technical points, regulatory standards, and development trends of surface wound absorption technology in the evaluation of medical dressings, providing a reference for the research, development, and evaluation of medical dressing products.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"231-236"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693675","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":"[Feasibility Study of Rapid Single-Voxel Point-Resolved Spectroscopy in 3.0 T Brain MRI].","authors":"Wei Wang, Jiahao Hu, Weinan Xu, Shengjie Hu","doi":"10.12455/j.issn.1671-7104.250398","DOIUrl":"10.12455/j.issn.1671-7104.250398","url":null,"abstract":"<p><strong>Objective: </strong>To explore the feasibility of the 3.0 T brain magnetic resonance single-voxel point-resolved spectroscopy (PRESS SV) fast imaging sequence under different parameter conditions and to compare it with the conventional PRESS sequence.</p><p><strong>Methods: </strong>Retrospectively, 200 patients who underwent brain magnetic resonance scans at the Integrated Traditional Chinese and Western Medicine Hospital of Wenzhou Medical University from September 2022 to August 2024 were selected, including 114 males and 86 females, with an average age of (47.12±11.47) years. Based on three parameter combinations-measured linewidth, total number of scans, and echo time (TE)-the patients were retrospectively divided into 5 groups: ①Control groups: small linewidth conventional short TE PRESS group (39 cases); ②Observation groups: large linewidth fast short TE PRESS group (39 cases), large linewidth fast long TE PRESS group (38 cases), small linewidth fast short TE PRESS group (40 cases), small linewidth fast long TE PRESS group (44 cases). To verify the influence of parameter variables, the control group underwent two conventional PRESS SV sequence scans; the observation groups underwent fast PRESS SV scans followed by an additional conventional PRESS SV scan as a control. The differences in metabolite SNR values and semi-quantitative values obtained from the two scans in each group were analyzed; Logistic regression analysis was performed on the parameters affecting image interpretation.</p><p><strong>Results: </strong>①The differences in metabolite semi-quantitative values between the two scans in all 5 groups were not statistically significant ( <i>P</i>＞0.05). ②The mean Cr SNR of the fast PRESS SV sequence was approximately (57.11±4.07)% of that of the conventional sequence, and the difference was statistically significant ( <i>P</i>＜0.05). ③For the large linewidth fast PRESS SV sequence with a voxel size of 4.5 cm ³, the image quality was poor, the rate of uninterpretable spectra was 1.5 to 2 times that of the conventional sequence. ④Logistic regression analysis showed that when the voxel size decreased from 8 cm ³ to 4.5 cm ³, the risk of uninterpretable images increased by 3.45 times; when the linewidth was ≥9 Hz, the risk increased by 2.09 times; and when TE=144 ms, the risk increased by 2.08 times.</p><p><strong>Conclusion: </strong>The 3.0 T brain fast PRESS SV sequence can replace the conventional PRESS SV sequence for clinical scanning, shortening the scan time; when the linewidth is ≥9 Hz, it is recommended to use a voxel size of 8 cm ³ or a TE of 35 ms to improve the success rate of imaging.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"195-200"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693694","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":"[Multi-Dimensional Modeling of Brain-Inspired Artificial Neural Networks and Its Application in Medical Image Analysis].","authors":"Caiwei Wang, Silin Chen, Xi Jiang, Dezhong Yao","doi":"10.12455/j.issn.1671-7104.250805","DOIUrl":"10.12455/j.issn.1671-7104.250805","url":null,"abstract":"<p><p>Brain-inspired Artificial Neural Networks (ANNs) have become a prominent research focus in the field of artificial intelligence, and their modeling framework has gradually evolved into a multidimensional development paradigm. This article systematically reviews the progress in this field and organizes it within a four-dimensional framework: ①structural modeling, which primarily focuses on neuron-level modeling and network topology optimization; ②functional modeling, emphasizing the abstract implementation of mechanisms such as attention, memory, cognition, and emotion; ③structure-function coupling, exploring tightly integrated modeling pathways between structure and function; ④brain-inspired learning mechanisms, concentrating on various biologically inspired learning rules and their behavioral manifestations. Special attention is given to insights derived from classical neuroscience model organisms, such as Caenorhabditis elegans, macaques, and other specific biological nervous systems, which contribute to the architectural design and energy efficiency optimization of brain-inspired ANNs. This framework provides a clearer analytical perspective for systematically comparing different brain-inspired models and integrating multiple mechanisms. Finally, the article summarizes the innovative applications of brain-inspired ANNs in medical image analysis, emphasizing their potential in spatiotemporal pattern modeling and highlighting key challenges, such as multimodal fusion. Future research will focus on deep integration of structure, function, and learning mechanisms, and further expand the application of brain-inspired intelligence in clinical and other real-world domains.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"167-180"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693627","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 Progress on Quality Evaluation of Drug-Loaded Contact Lenses].","authors":"Zhuoyu Song, Zhenqi Liu, Jianfeng Shi, Yuanli Huang, Qianqian Han, Chunmeng Sun","doi":"10.12455/j.issn.1671-7104.250377","DOIUrl":"10.12455/j.issn.1671-7104.250377","url":null,"abstract":"<p><p>As a novel ocular drug delivery system, drug-loaded contact lenses have overcome the limitations of traditional ophthalmic drug formulations and possess characteristics such as high bioavailability, low toxicity and side effects, and prolonged effective drug delivery. Currently, the majority of researches on drug-loaded contact lenses remain in the developmental design or preclinical stages. This article provides a comprehensive summary and discussion of the quality evaluation methods for drug-loaded contact lenses in recent years, focusing on aspects of efficacy, safety, and physicochemical properties.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"188-194"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693658","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 the Design of Proton Therapy Monitoring System Based on Domestic SCADA Platform].","authors":"Yifan Liu, Feiyang Han, Zhiwu Guo, Da Huang, Hongliang Zhang","doi":"10.12455/j.issn.1671-7104.250553","DOIUrl":"10.12455/j.issn.1671-7104.250553","url":null,"abstract":"<p><p>Proton therapy monitoring system is an important component of proton therapy system. In view of the high-precision and high-reliability requirements of proton therapy equipment for the monitoring system, this paper presents a design scheme of proton therapy monitoring system based on the domestic SCADA (supervisory control and data acquisition) platform. The system is divided into four layers: equipment layer, data acquisition layer, data processing layer and data display layer. The functions of each layer are constructed and integrated in the form of module sets or interfaces. Through real-time acquisition, processing and analysis of the operation parameters of proton therapy equipment, the system realizes state monitoring and process control of the proton therapy process, which is a practical attempt to apply the domestic SCADA platform in the high-end medical field.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"207-211"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693709","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 of an Automated Test System for Pacing Performance].","authors":"Ya Chen, Yumin Fan, Xiaoqing Zhang","doi":"10.12455/j.issn.1671-7104.250244","DOIUrl":"10.12455/j.issn.1671-7104.250244","url":null,"abstract":"<p><p>This study presents the design of an automated control system based on LabVIEW development technology, aiming to develop a high-precision and fully automated pacing performance testing system. The system enables automatic control of parameter configuration, test item selection and so on. It significantly improves testing efficiency while ensuring measurement accuracy, and it provides an efficient testing platform for type inspections, thereby promoting the rapid and orderly development of the domestic cardiac pacemaker industry and accelerating the localization of high-end medical devices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"212-216"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693711","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 of an Automated Multi-Point Acupoint Moxibustion Robot].","authors":"Jiale Huang, Chao Yu, Xu Zhou, Mengfei Yuan, Xianjun Yang, Meng Li","doi":"10.12455/j.issn.1671-7104.250582","DOIUrl":"10.12455/j.issn.1671-7104.250582","url":null,"abstract":"<p><p>To address the issues of existing moxibustion robots relying on manual guidance for acupoint recognition, the separation of acupoint identification and moxibustion therapy, and the complexity of multi-point acupoint moxibustion operations, this paper designs an automated moxibustion robot based on multi-point acupoint recognition. The robot consists of a base, a six-axis robotic arm, an end-effector moxibustion box, an RGB-D camera, and a control system. The control system employs image measurement and recognition algorithms to accurately acquire the coordinates of acupoints marked by therapists. These coordinates are then transformed into the robotic arm's base frame using a hand-eye calibration matrix, enabling automatic acupoint recognition and motion control of the robotic arm. Additionally, the system supports automated path planning for multi-point acupoints, personalized settings for moxibustion duration and temperature, and the simulation of various moxibustion techniques, including suspended moxibustion, circular moxibustion, and sparrow-pecking moxibustion. The system achieves a positioning error of ≤5 mm for multiple acupoint markers. This study effectively resolves the challenges of automatic multi-point acupoint recognition and the simulation of diverse moxibustion techniques, demonstrating broad market potential and application prospects.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"135-142"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693588","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}