中国医疗器械杂志最新文献

{"title":"[Research on the Value of Density Resolution for Precision Optimization of Medical Imaging Technology].","authors":"Fenghua Dong, Xuhui Liao, Jie Su, Linjie Li, Luping Feng, Gaoqiang Yang, Shimeng Xu","doi":"10.12455/j.issn.1671-7104.250619","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250619","url":null,"abstract":"<p><p>This paper conducts a systematic study focusing on the key role of density resolution in medical imaging. Density resolution stands as a critical performance metric in medical image quality assessment, directly determining an imaging system's capability to discern subtle density differences between tissues. It fundamentally reflects the capacity of imaging equipment to differentiate adjacent anatomical structures with similar signal characteristics. Enhancing density resolution significantly improves sensitivity in detecting early pathological changes, thereby providing more reliable imaging evidence for clinical decision-making. With the growing demands of precision medicine and early disease screening, improving density resolution while maintaining imaging efficacy and safety has emerged as a pressing challenge in medical imaging technology development. This study conducts a comprehensive analysis from multiple perspectives: the principles and threshold analysis of density resolution, influencing factors and performance enhancement strategies, along with technical safeguards and future challenges. The research systematically elaborates on technical optimization pathways for precision improvement in this field.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"367-373"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867756","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":"[Advances and Challenges in Photoacoustic-Ultrasound Dual-Modality Imaging: from Hardware Innovations to Clinical Applications].","authors":"Yangjie Sheng, Zheng Sun","doi":"10.12455/j.issn.1671-7104.250444","DOIUrl":"10.12455/j.issn.1671-7104.250444","url":null,"abstract":"<p><p>Photoacoustic-ultrasound dual-modal imaging represents an emerging hybrid imaging technique that combines the functional advantages of photoacoustic imaging with the high-resolution structural characterization capabilities of ultrasound imaging. This article comprehensively summarizes the research status and progress from both system-level and algorithmic perspectives. In hardware development, breakthroughs in novel ultrasound transducers and multimodal probe architecture designs have significantly enhanced tissue penetration depth and signal acquisition efficiency while reducing system complexity. In terms of imaging algorithms, the synergistic innovation of physics-model-driven and data-driven approaches has achieved precise quantitative reconstruction of optical absorption parameters and sound velocity. In particular, deep learning frameworks employing multimodal feature fusion and adaptive optimization strategies have effectively addressed the limitations of conventional methods in noise suppression and computational efficiency. This article not only provides a reference for theoretical research and clinical applications of multi-modal imaging technology but also explores its broad prospects in the development of intelligent diagnostic / therapeutic devices and precision medicine practices.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"379-390"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148868030","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 Optimization of Fixed-Term Scrapping System for Medical Equipment: Taking Defibrillators as an Example].","authors":"Siyuan Xie, Nanxin Feng, Litian Fan, Qilin Liu","doi":"10.12455/j.issn.1671-7104.250853","DOIUrl":"https://doi.org/10.12455/j.issn.1671-7104.250853","url":null,"abstract":"<p><strong>Objective: </strong>To address the prevalent issue of resource waste caused by the \"fixed-term scrapping\" policy in medical device management, this study aims to establish a scientific residual value evaluation system based on real-world data (RWD). The goal is to provide theoretical and empirical evidence for optimizing medical resource allocation and breaking the traditional rigid age-based mandatory retirement model.</p><p><strong>Methods: </strong>Defibrillators, a typical category of emergency equipment in a large tertiary Grade A hospital, were selected as the pilot sample. A technical evaluation model incorporating the Process Capability Index ( <math> <msub> <mrow><mrow><mi>C</mi></mrow> </mrow> <mrow><mrow><mi>p</mi></mrow> <mrow><mi>k</mi></mrow> </mrow> </msub> </math> ) and a health economic evaluation model based on the replacement cost method were constructed. A retrospective analysis was conducted on 191 valid quality control records from 85 in-use devices to quantitatively evaluate the actual performance status and potential economic value of devices serving beyond their recommended lifespan.</p><p><strong>Results: </strong>Empirical analysis demonstrated no significant linear correlation between the service life of defibrillators and their core performance. Under standardized maintenance, 37.6% of the devices that had served for over 12 years still exhibited excellent process capability ( <math> <msub> <mrow><mrow><mi>C</mi></mrow> </mrow> <mrow><mrow><mi>p</mi></mrow> <mrow><mi>k</mi></mrow> </mrow> </msub> <mo>></mo> <mrow><mn>1</mn></mrow> <mo>.</mo> <mrow><mn>33</mn></mrow> </math> ). Implementing a condition-based service life management strategy for this specific category of equipment alone could theoretically save the hospital approximately <math><mrow><mi>¥</mi> </mrow> <mrow><mn>1</mn></mrow> <mo>,</mo> <mrow><mn>152</mn></mrow> <mo>,</mo> <mrow><mn>000</mn></mrow> </math> in replacement costs.</p><p><strong>Conclusion: </strong>The current fixed-term scrapping system for medical equipment poses a significant risk of resource misallocation. This study validates the effectiveness of a dual-dimensional (technical and economic) evaluation model in identifying the residual value of equipment. It is suggested that medical institutions implement classified management based on device characteristics-establishing a hierarchical life-extension management catalog based on the <math> <msub> <mrow><mrow><mi>C</mi></mrow> </mrow> <mrow><mrow><mi>p</mi></mrow> <mrow><mi>k</mi></mrow> </mrow> </msub> </math> index-to achieve refined fixed assets management and significant cost efficiency while ensuring medical safety.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 4","pages":"424-429"},"PeriodicalIF":0.0,"publicationDate":"2026-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148867703","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":"[Deep Learning-Based Automatic Segmentation Model for Radiotherapy Target Delineation of Brain Metastases and Its Clinical Applications].","authors":"Shizhao Sun, Wenguang He, Gangqiang Xiong","doi":"10.12455/j.issn.1671-7104.250339","DOIUrl":"10.12455/j.issn.1671-7104.250339","url":null,"abstract":"<p><strong>Objective: </strong>To develop an automatic segmentation model based on a U-shaped convolutional neural network (U-Net) for delineating the gross tumor volume (GTV) in Gamma knife radiotherapy for brain metastases, and to evaluate its accuracy, efficiency and clinical applicability compared with manual delineation by junior clinicians.</p><p><strong>Methods: </strong>A total of 100 patients with brain metastases who underwent Gamma Knife treatment were included, and the model was trained using data augmentation techniques. Using contours delineated by senior clinicians as the gold standard, the model and junior clinicians were compared in terms of the Dice similarity coefficient (DSC), Hausdorff distance (HD), total time consumption, single-sample processing time, average symmetric surface distance (ASSD), and maximum symmetric surface distance (MSSD).</p><p><strong>Results: </strong>The mean DSC for the model and junior clinicians were 0.84 and 0.74, respectively, while the average single-case processing times were 1.8 minutes and 14.2 minutes, respectively. The differences in segmentation accuracy between the two groups were statistically significant ( <i>P</i><0.05).</p><p><strong>Conclusion: </strong>The proposed U-Net+GTV model outperforms junior clinicians in accuracy, efficiency, and stability, demonstrating considerable potential for clinical application in GTV delineation for Gamma knife radiotherapy.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"237-244"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310103","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 Application of 3D-Printed Individualized Pelvic Prostheses].","authors":"Mingyang Li, Chunbao Shi, Kunbo Wang, Fengbao Xie, Yan Wang, Bing Liu, Zhuangzhuang Li","doi":"10.12455/j.issn.1671-7104.250588","DOIUrl":"10.12455/j.issn.1671-7104.250588","url":null,"abstract":"<p><strong>Objective: </strong>This article describes the design and fabrication of individualized pelvic prostheses by integrating three-dimensional (3D) printing technology with design software, and evaluates their feasibility and clinical efficacy.</p><p><strong>Methods: </strong>Based on the patient's anatomical structure and biomechanical requirements, individualized pelvic prostheses were designed using digital reconstruction software, manufactured by combining 3D printing and machining technologies, and finally verified for feasibility through clinical application.</p><p><strong>Results: </strong>Through adequate doctor-engineer interaction and detailed preoperative planning, precise individualized resection of the patient's tumor range was completed; guided by the pelvic tumor classification theory, individualized pelvic prostheses were designed and manufactured. Clinical application showed that the prostheses were consistent with the surgical plan and accurately implanted, with complete postoperative pelvic reconstruction and good healing.</p><p><strong>Conclusion: </strong>This article summarizes the previous theoretical basis and sorts out the key design points of prostheses corresponding to different pelvic defect classifications; by using digital reconstruction software, combined with 3D printing technology and machining processes, the design and fabrication of individualized pelvic prostheses were completed; the feasibility and effect of the prosthesis design were verified through clinical application, providing a new approach for clinical medicine to repair defects after pelvic tumor osteotomy and other special lesions.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"319-325"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310054","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":"[Non-Contact Physiological Signal Monitoring Technology: Potential and Applications of BCG].","authors":"Haolin Xu, Xiaomei Wu","doi":"10.12455/j.issn.1671-7104.250716","DOIUrl":"10.12455/j.issn.1671-7104.250716","url":null,"abstract":"<p><p>This paper reviews the development history, signal mechanisms, and typical waveform characteristics of ballistocardiography (BCG) as a physiological monitoring technology. It also summarizes signal processing methods, including preprocessing, feature extraction, and deep learning. Drawing on the latest research, the paper discusses current applications in cardiovascular monitoring, sleep and respiration analysis, and exercise assessment. Furthermore, it addresses key challenges related to cross-device consistency and explores future directions for the development of BCG technology, offering a comprehensive reference for its research and application.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"267-273"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310032","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":"[Test-Retest Reliability Assessment of CT Subjective and Objective Resolution under Differentiated Scanning Parameters].","authors":"Wei Jin, Ruiyao Jiang","doi":"10.12455/j.issn.1671-7104.250841","DOIUrl":"10.12455/j.issn.1671-7104.250841","url":null,"abstract":"<p><p><b>Objective</b> Based on existing CT performance testing methods, the test-retest reliability of subjective and objective results for both spatial resolution and low-contrast detectability were evaluated and analyzed under different scanning conditions. <b>Methods</b> A prospective research method was adopted, using clinical routine scanning protocols and parameters for the head, chest and abdomen. Eight CT scanners from different regions underwent two rounds of testing, with each round tested three times. The coefficient of variation (CV) and intraclass correlation coefficient (ICC) were used to evaluate inter-CT test-retest reliability. Bland-Altman analysis was used to evaluate intra-CT test-retest reliability. <b>Results</b> For head scanning, the CV range for spatial resolution was 8.85%-21.66%, with ICCs from 0.26 to 0.72; the CV range for density resolution was 5.53%-47.84%, with ICCs from 0.16 to 0.75. For chest scanning, the CV range for spatial resolution was 9.13%-19.65%, with ICCs from 0.41 to 0.75; the CV range for density resolution was 12.25%-38.89%, with ICCs from 0.18 to 0.68. For abdomen scanning, the CV range for density resolution was 5.91%-37.33%, with ICCs from 0.23 to 0.77. For the same CT, the successive results of subjective spatial resolution from head protocols demonstrated statistical significance under the first enhancement strength. Moreover, the successive results of objective spatial resolution from chest protocols demonstrated statistical significance under the first, second and third enhancement level. No statistical significance was observed under other scanning conditions. <b>Conclusion</b> The objective contrast evaluation method demonstrated better variability and consistency compared to the subjective evaluation method under most test conditions. Even for the same CT with iterative reconstruction algorithm at the same levels, there may exist statistical significance of the spatial resolution values from successive head and chest scanning. Cautions should be taken when test results of objective spatial resolution are analyzed.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"259-266"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310348","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 Portable Sleep Monitoring System].","authors":"Youguo Hao, Rui An, Jinxiu Xu, Jie Zhang, Yang Xu","doi":"10.12455/j.issn.1671-7104.250679","DOIUrl":"10.12455/j.issn.1671-7104.250679","url":null,"abstract":"<p><p>With the accelerated pace of modern life and the increasing pressure, the population affected by sleep disorders is expanding. Traditional polysomnography (PSG), though recognized as the gold standard for sleep monitoring, relies on wired connections and is restricted to hospital settings. This not only disrupts natural sleep patterns but also elevates the risk of data misinterpretation. Existing portable monitoring devices, however, have drawbacks such as limited monitoring parameters, inadequate medical-grade accuracy, or poor wearing comfort. In this study, a portable sleep monitoring system is developed, which adopts a modular wireless integrated architecture. A relay control box is used to receive data from electroencephalogram (EEG), electrocardiogram (ECG), and blood oxygen acquisition modules <i>via</i> Bluetooth. The system supports dual-path data transmission to the host computer through Wi-Fi/RS485, thus eliminating the constraints of wired connections. Performance tests confirm that the key performance indicators of the system meet national and industrial technical standards. Furthermore, the system is characterized by its compact size, easy wearing, and high comfort, making it applicable for popularization in home sleep monitoring scenarios.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"326-333"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310082","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 Coordinated Mechanism of Medical Device Research and Evaluation in China and the United States].","authors":"Jianan Ma, Haolin Li, Yaohua Li","doi":"10.12455/j.issn.1671-7104.250539","DOIUrl":"10.12455/j.issn.1671-7104.250539","url":null,"abstract":"<p><p>In recent years, the medical device industry has developed rapidly, with new technologies and products constantly emerging. Consequently, the demand for pre-registration communication services has increased. Through literature and policy analysis, this paper systematically reviews the institutional policies and implementation pathways of the coordinated mechanism for research and evaluation in China and the United States, and compares and analyzes the differences between the two systems. The paper proposes insights for reforming China's medical device review and approval policies, thereby promoting industrial innovation and high-quality development.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"342-346"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310358","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 Temperature-Sensitive Fluorescent Nanomaterials in Biomedical Field].","authors":"Bin Liu, Fuyu Zhu, Xiaohui Yu, Lili Liu, Dong Liu, Jianzhong Huang","doi":"10.12455/j.issn.1671-7104.250486","DOIUrl":"10.12455/j.issn.1671-7104.250486","url":null,"abstract":"<p><p>This review summarized recent advances in thermosensitive fluorescent nanomaterials for biomedical applications, focusing on their use in intracellular temperature monitoring, tumor-microenvironment sensing, and the construction of multifunctional theranostic platforms. These nanomaterials exhibited fluorescence changes in response to external stimuli, offering non-invasive, real-time feedback with high spatiotemporal resolution. Temperature variations could be reported through multiple optical parameters such as emission intensity and peak position. For intracellular thermometry, they enabled real-time tracking of temperature fluctuations within living cells, providing crucial insights into cellular physiology. In tumor-microenvironment monitoring, they detected localized temperature alterations, facilitating early diagnosis and guiding therapy. Under photothermal treatment, the nanomaterials were delivered to tumor sites and, upon laser irradiation, generated localized hyperthermia to selectively ablate cancer cells. Nevertheless, clinical translation still faced challenges, including long-term biosafety evaluation, stability in complex physiological environments, and optimization of response accuracy. Future research would concentrate on developing materials with higher biocompatibility and intelligent responsiveness, integrating multimodal sensing and multifunctional capabilities, achieving subcellular-organelle targeting for precision therapy, promoting synergistic tumor-specific hyperthermia and chemotherapy, and ultimately constructing \"all-in-one\" theranostic platforms.</p>","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"50 3","pages":"298-305"},"PeriodicalIF":0.0,"publicationDate":"2026-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148310374","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}