中国医疗器械杂志最新文献

{"title":"[Research Progress and Future Perspectives on Minimally Invasive Fracture Reduction Techniques].","authors":"Li Qiao, Hua Guo, Jianghong Wu","doi":"10.12455/j.issn.1671-7104.250335","DOIUrl":"10.12455/j.issn.1671-7104.250335","url":null,"abstract":"<p><p>With the increase of road traffic injuries, sports injuries, and the growing elderly population, the global incidence of fractures has been steadily rising. At present, with the development of novel instruments and techniques, minimally invasive treatment of fractures has made substantial progress. Nevertheless, the current clinical application of such techniques remains relatively limited, as they can only be used in patients with non-displaced or minimally displaced fractures. This is mainly because it is extremely difficult for surgeons to achieve accurate reduction of deep fractures under closed surgical conditions. In recent years, with the cross-integration of disciplines such as medical, computer, engineering and communications technologies, some progress has been made in the field of minimally invasive fracture reduction. This article reviews the reduction techniques based on external fixator, 3D printing technology, surgical navigation systems, and surgical robots.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"290-297"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310418","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 and Application Prospects of Saliva-Based Point-of-Care Testing Technologies].","authors":"Qian Dou, Liping Zhu, Jiaying Ni, Tingjun Chen, Chun Xu, Lingyong Jiang, Chao Yuan, Tifei Yuan, Dan Wang, Jingjing Zhou, Jiahui Niu, Lili Zhang, Haijian Guo, Jingxu Chen, Xinhua Xiao, Jian Zhou, Qing Dai","doi":"10.12455/j.issn.1671-7104.250439","DOIUrl":"10.12455/j.issn.1671-7104.250439","url":null,"abstract":"<p><p>Saliva, as a biological sample capable of reflecting the physiological and pathological status of the body, holds significant application value in disease screening and monitoring due to its advantages such as ease of collection, safety, and non-invasiveness. To promote its efficient use in clinical practice, the development of point-of-care testing (POCT) technologies for saliva is key to providing rapid, accurate, and cost-effective diagnostic solutions. In light of this, this article systematically reviews the latest advances in POCT technologies for salivary biomarkers, covering a variety of methods including dry chemistry, immunochromatography, chemiluminescence, electrochemistry, quartz crystal microbalance (QCM), surface plasmon resonance (SPR), microfluidics, biochips, molecular diagnostics, and artificial intelligence-assisted diagnostics. It focuses on representative technologies and products that are either commercially available or have translational potential, delving into their technical principles, design concepts, performance metrics, and application scenarios. Finally, the article summarizes the key challenges and future opportunities facing saliva POCT technologies in the process of clinical translation, aiming to provide academic support for their further research advancement and industrial development.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"274-289"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310395","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 Automatic Detection Method of Spatial Resolution for CT Systems Based on the Catphan500 Phantom].","authors":"Jin Li, Wei Jin, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.250842","DOIUrl":"10.12455/j.issn.1671-7104.250842","url":null,"abstract":"<p><strong>Objective: </strong>To explore an automated, rapid, and objective method for measuring CT device spatial resolution based on the Catphan500 phantom.</p><p><strong>Methods: </strong>Prospectively collected quality control images from CT devices of different models across various hospitals, trained them using the YOLOv8 deep learning model, and compared the results with manual measurement methods to validate reliability.</p><p><strong>Results: </strong>The YOLOv8 deep learning model achieved a recall of 98%, a precision of 96%, and an mAP@0.5 of 0.988 on the test set, demonstrating excellent performance. The automated detection method measured a single image in an average of only 0.128 seconds, significantly outperforming manual measurement, with only slight differences observed at the extreme resolution.</p><p><strong>Conclusion: </strong>The YOLOv8 deep learning model provides a highly accurate and stable method for automated detection of CT spatial resolution based on the Catphan500 phantom, reducing manual intervention and measurement errors, and offering reliable technical support for the standardization and automation of CT device quality control.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"253-258"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310253","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 and Countermeasure Analysis on the Classification of Brain-Computer Interface Rehabilitation Medical Devices].","authors":"Yue Wang, Xiao Jiang, Le Cui, Xiao Cao, Run Shi, Yue Wang, Kejun Liu, Chunqing Zhang, Jiong Zhu","doi":"10.12455/j.issn.1671-7104.250541","DOIUrl":"10.12455/j.issn.1671-7104.250541","url":null,"abstract":"<p><strong>Objective: </strong>To explore the current management status and challenges of brain-computer interface (BCI) rehabilitation medical devices. The existing classification system in China faces several problems, including a single classification dimension, insufficient risk adaptation, and having difficulties in coping with technological iteration. This study aims to propose scientific classification ideas and promote the healthy and orderly development of such devices in the medical field.</p><p><strong>Methods: </strong>By sorting out the regulatory experience of the United States, the European Union and Japan, combining the current situation of BCI technology research and classification management in China, this study analyzes the technical characteristics of BCI products and the current status of \"ambiguous definition and classification, and pending update of regulations and standards\". On this basis, a three-dimensional classification model based on \"function, risk and invasiveness\" is constructed.</p><p><strong>Results: </strong>The core function of these products is defined as \"collecting electroencephalographic signals to identify patients' intentions for rehabilitation training or adjuvant therapy\". Subdivisions such as \"invasive/non-invasive\" and \"rehabilitation training/augmentative and alternative communication/mental illness treatment\" are achieved. For example, multi-functional devices for stroke patients are classified as \"medium risk\". International practices are integrated to overcome the limitations of traditional classification, providing a path for China to learn from international ideas. Space is reserved for technological iteration, such as new electrodes and artificial intelligence algorithms.</p><p><strong>Conclusion: </strong>By clarifying functional purposes and risks, the proposed classification idea provides a basis for supervision. It can be optimized with the expansion of technology and scenarios, and it helps make the classification of BCI products more scientific <b>.</b></p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"334-341"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310287","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 Subcutaneous Diffusion of Drug Solution in Pneumatic Needle-Free Injectors].","authors":"Qingjiang Xiang, Zhang Huang, Chunwei Du, Shiji Zhao","doi":"10.12455/j.issn.1671-7104.250297","DOIUrl":"10.12455/j.issn.1671-7104.250297","url":null,"abstract":"<p><p>The needle-free injection has broad application prospects in medical fields such as treatment or vaccination prevention. However, there is insufficient understanding of the diffusion dynamics of needle-free injection micro-jets under the skin, which affects the accuracy of this technology in subcutaneous drug delivery. The pneumatic needle-free injector was selected to carry out high-speed photography tests of the gel injection process, and the Smoothed Particle Hydrodynamics method was used to carry out the simulation of the injection process. The diffusion size obtained from the simulation was compared with the observation results. The results indicate that: when the nozzle diameters are 0.14, 0.25, and 0.32 mm, and the injection dose ranges from 0.1 mL to 0.3 mL, the maximum diffusion depth <i>L</i> _d increases from 16.3 mm to 27.5 mm as the nozzle diameter increases, representing a change rate exceeding 60%. When the nozzle diameter is fixed while varying the dosage, the diffusion width <i>L</i> _w increases from 12.8 mm to 17.1 mm. It was concluded that the injection dose has a more significant impact on the diffusion width of the drug solution, whereas the nozzle diameter exerts a greater influence on the diffusion depth. Numerical simulations revealed the formation and propagation process of the stress wave as the drug solution jet penetrates into the gel, along with the position-time-stress waveform diagram. These findings validate the conclusion that the diameter of the wound formed during the needle-free injection process corresponds to the nozzle diameter. By adjusting the nozzle diameter and injection dose, precise injection depth and the anticipated diffusion pattern of the drug solution can be achieved. These research outcomes provide a theoretical foundation for optimizing needle-free injection parameters.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"245-252"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310295","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":"[Reliability Analysis of Wide-Detector CT Equipment Based on Improved FMEA].","authors":"Wenhao Xu, Wei Jin, Shundong Hu","doi":"10.12455/j.issn.1671-7104.250849","DOIUrl":"10.12455/j.issn.1671-7104.250849","url":null,"abstract":"<p><strong>Objective: </strong>An improved failure mode and effects analysis (FMEA) model is constructed to enhance the accuracy of reliability assessment for wide-detector computed tomography equipment.</p><p><strong>Methods: </strong>A multidisciplinary expert panel is established. A scoring system is used to quantitatively evaluate various potential failure modes, and expert weights are introduced for weighted calculation to achieve objective ranking of risk priority.</p><p><strong>Results: </strong>The overheating of the X-ray tube and system communication interruption are identified as the highest-risk failure modes. Significant differences in equipment reliability under different clinical usage patterns are quantitatively revealed.</p><p><strong>Conclusion: </strong>The improved FMEA method can effectively identify key failure links, providing a reliable basis for formulating differentiated and precise preventive maintenance strategies, which is helpful for ensuring the continuous and stable operation of equipment.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"306-310"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310270","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":"[Study on Standardization Methods of Multi-Source Heterogeneous Data from ICU Medical Devices Based on openEHR].","authors":"Lingdong Chen, Hailing Cai, Zhenya Wang, Zheng Chen, Jing Li, Yabin Xu, Jian Huang","doi":"10.12455/j.issn.1671-7104.250158","DOIUrl":"10.12455/j.issn.1671-7104.250158","url":null,"abstract":"<p><strong>Objective: </strong>To address the challenges of multi-source heterogeneous data from ICU medical devices in terms of structure, semantics, and standardization, this study explores a standardized modeling approach based on openEHR. The aim is to achieve unified management and efficient utilization of data, providing a solid data foundation for smart healthcare and evidence-based medicine.</p><p><strong>Methods: </strong>This research is grounded in the dual-layer modeling architecture of openEHR. A medical devices data prototype and corresponding templates tailored for the ICU context were designed and constructed, enabling standardized semantic expression and unified encoding of multi-source heterogeneous data. Through multi-protocol standardization mapping, unified acquisition and parsing of device data from different vendors, protocols, and data structures were achieved. Furthermore, a data platform for ICU medical devices was established, facilitating dynamic data collection, real-time standardization processing, and semantic unification.</p><p><strong>Results: </strong>In a practical application at a tertiary A-grade hospital's ICU, the modeling of 98 prototypes for 8 types of devices (including ventilators and patient monitors) and encapsulated 8 clinical scenario templates were completed. The efficiency of device data integration was significantly improved. The time required for preparing clinical research data was reduced from an average of 4.2 hours to 0.5 hours.</p><p><strong>Conclusion: </strong>The standardized modeling method based on openEHR effectively addresses the heterogeneity data issues from ICU medical devices. Its open model-driven architecture supports cross-device interoperability and long-term evolution, providing high-quality data foundations. This approach optimizes clinical decision-making processes and enhances data management efficiency, offering a systematic solution for the effective integration and semantic governance of multi-source heterogeneous data.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"311-318"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310407","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 CT X-Ray Tube Life Cycle Stage Prediction Based on Operational Data].","authors":"Nanxin Feng, Siyuan Xie, Litian Fan, Zhu Chen, Qilin Liu","doi":"10.12455/j.issn.1671-7104.250760","DOIUrl":"10.12455/j.issn.1671-7104.250760","url":null,"abstract":"<p><p>This study aims to propose and validate a method for predicting the lifecycle stage of CT X-ray tubes using short-term equipment operational data. Detailed operational logs of five CT scanners over a three-month period, along with long-term tube replacement records, were collected from a large tertiary A-grade hospital. The Kaplan-Meier survival analysis method and log-rank test were employed to screen for the optimal lifespan metric. Combined with thermal reaction equations, 15 features quantifying workload were extracted. The lifespan prediction problem was transformed into a four-stage classification task, which was trained and evaluated using six machine learning models. Total scan volume and total exposure seconds reflected the tube degradation process more effectively than calendar days. The Random Forest (RandomForest) model achieved the best predictive performance, with a 5-fold cross-validation accuracy of 89.2% and an F1-score of 0.892. Feature importance analysis confirmed that indicators of cumulative energy consumption and usage intensity were highly correlated with the tube's lifecycle stage, a pattern consistent with physical degradation laws. Utilizing short-term operational data combined with machine learning models allows for high-precision prediction of the lifecycle stage of CT X-ray tubes. This method provides a reliable decision-support tool for healthcare institutions to implement low-cost and efficient predictive maintenance.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"201-206"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693632","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 Analysis of a Rigid-Flexible Hybrid Fracture Reduction Robot].","authors":"Qing Zhu, Di Jiang, Deyu Tu","doi":"10.12455/j.issn.1671-7104.250395","DOIUrl":"10.12455/j.issn.1671-7104.250395","url":null,"abstract":"<p><p>To address the technical bottlenecks of minimally invasive closed reduction and intramedullary nailing (IMN), a rigid-flexible hybrid minimally invasive fracture reduction robot is proposed. The system leverages the compliant contact properties and continuous deformation capabilities of soft materials to ensure reduction accuracy while satisfying the compliance and safety requirements of the fracture reduction process. Additionally, based on the anatomical and physiological characteristics of the human lower limbs, a femoral shaft fracture model is developed, accounting for the presence of soft tissues such as muscles around the fracture site. Subsequently, fracture reduction simulation experiments are conducted on the model using the proposed robot following clinical surgical reduction protocols. After reduction, the maximum angular error is 0.6°, and the maximum residual translation is 1.0 mm. Results demonstrate that the proposed system meets the clinical functional reduction criteria, ensuring precision while enhancing human-robot interaction safety. It exhibits potential advantages in meeting the demands of low radiation, lightweight design, and high compliance in fracture reduction surgeries.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"129-134"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693626","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":"[A Feasibility Study on Bioradar Eye Movement Detection for Sleep Stage Classification].","authors":"Tingwei Lei, Yuan Zhou, Minghao Bai, Yunting Duan, Tianjiao Guo, Qiang An, Lantao Liu, Hao Lyu","doi":"10.12455/j.issn.1671-7104.250761","DOIUrl":"10.12455/j.issn.1671-7104.250761","url":null,"abstract":"<p><p>To address the problem of low classification accuracy in existing bioradar sleep staging technology caused by the use of indirect physiological features, research on bioradar sleep eye movement detection is conducted. A synchronous acquisition platform for millimeter-wave bioradar and electrooculogram (EOG)/polysomnography (PSG) is established. Simulated eye movement experiments and real sleep experiments are carried out respectively. In the simulated eye movement experiments, the time-domain cross-correlation coefficient between the eye movement signals detected by the bioradar and the EOG signals exceeds 0.90. The error in the dominant frequency within the frequency domain is less than 0.05 Hz. In the real sleep experiments, eye movement signals consistent with EOG are also detected by the bioradar. These signals exhibit explosive characteristics in the rapid eye movement period, intermittent smooth fluctuation characteristics in the light sleep period, and stable low-amplitude fluctuation characteristics in the deep sleep period. The experimental results indicate that the bioradar can effectively detect and distinguish three typical sleep eye movement events: rapid eye movement, slow eye movement, and no significant eye movement. This provides a new technical approach for bioradar sleep staging, which holds promise for further improving staging accuracy.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 2","pages":"152-159"},"PeriodicalIF":0.0,"publicationDate":"2026-03-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147693576","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}