中国医疗器械杂志最新文献_第3页

[Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA]. 【医疗领域脑机接口技术分析及美国FDA监管】。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240187

Jiaying Guo, Jieying Yang, Yaohua Li

{"title":"[Analysis of Brain-Computer Interface Technology in the Medical Field and the Regulation of the US FDA].","authors":"Jiaying Guo, Jieying Yang, Yaohua Li","doi":"10.12455/j.issn.1671-7104.240187","DOIUrl":"10.12455/j.issn.1671-7104.240187","url":null,"abstract":"Brain-computer interface (BCI) technology is an innovative and cutting-edge medical advancement that enables direct interaction between the brain and external devices, facilitating the reconstruction of daily functions for patients or serving as a method for neuro-regulation therapy. Although this technology offers a broad range of clinical applications, there are problems as potential risks, individual variations, and the need for long-term monitoring of its effects during utilization. Consequently, the comprehensive evaluation of its safety and effectiveness poses a considerable challenge for regulatory agencies. This study provides a concise introduction to the development history and various types of BCI technology, followed by a summary of the regulatory situation for different types of BCI medical devices in the United States. Furthermore, the regulatory requirements imposed by the US FDA on this product category are analyzed. Finally, the article concludes by presenting a summary and future perspective on the current development of BCI technology, with the aim of offering beneficial insights and guidance for the regulation of BCI medical devices.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"96-102"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494743","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}

引用次数: 0

[Study on Pre-Clinical In-Vitro Test Methods of Unicondylar Knee Prosthesis]. 单髁膝关节假体临床前体外测试方法研究

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240327

Shu Yang, Dan Han, Wen Cui, Zhenxian Chen, Jinju Ding, Jintao Gao, Bin Liu

引用次数: 0

[Application Research of mDIXON-Quant Quantitative T2* Values and FF Values in Cervical Intervertebral Disc Degeneration]. [mdixon -定量T2*值和FF值在椎间盘退变中的应用研究]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240348

Peng Liu, Meichen Niu, Hong Liu

{"title":"[Application Research of mDIXON-Quant Quantitative T2* Values and FF Values in Cervical Intervertebral Disc Degeneration].","authors":"Peng Liu, Meichen Niu, Hong Liu","doi":"10.12455/j.issn.1671-7104.240348","DOIUrl":"10.12455/j.issn.1671-7104.240348","url":null,"abstract":"Objective: To investigate the clinical value of MRI modified water-lipid separation technique (mDIXON-Quant) in terms of T2* values and fat fraction (FF) values for evaluating the degree of cervical intervertebral disc degeneration.Methods: A total of 118 patients who underwent routine MRI of the cervical vertebra and the mDIXON-Quant examination in Fuyang People's Hospital from March 2019 to January 2024 were collected. The T2* values of C2/3 to C6/7 intervertebral discs and FF values of the upper and lower vertebral bodies were measured. Cervical intervertebral disc degeneration was graded according to the Pfirrmann criteria. The T2* values and FF values of different patients were compared with the Pfirrmann grades, and the correlation between T2* values, FF values, and Pfirrmann grades was analyzed by Spearman correlation.Results: The T2* values of cervical intervertebral discs in grades I, II, III, IV, and V all showed a decreasing trend ( P＜0.05). The decreasing order of FF values in the upper cervical vertebra was IV, V, III, II, and I ( F=93.28, P＜0.05), and the decreasing order of FF values in the lower cervical vertebra was IV, III, V, II, and I ( F=112.037, P＜0.05). Spearman correlation analysis showed that the T2* values of cervical intervertebral discs were negatively correlated with the Pfirrmann grades ( P＜0.05), and the FF values of the upper and lower vertebrae were positively correlated with the Pfirrmann grades ( P＜0.05).Conclusion: The mDIXON-Quant technique can be used to quantify the T2* values and FF values of cervical intervertebral disc degeneration and plays an important role in accurate clinical diagnosis and evaluation of treatment effects.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"61-66"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494751","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}

引用次数: 0

[Comparative Research on Regulatory Requirements of Radiotherapy Equipment Across Countries]. 【各国放疗设备监管要求比较研究】。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240302

Chao Sun, Yue Yu, Hong Fang, Jingting Du, Yu Tang

引用次数: 0

[Evaluation of Clinical Practicability of Hybrid Automatic Treatment Planning for Nasopharyngeal Carcinoma]. 鼻咽癌混合自动治疗方案临床实用性评价

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240159

Enwei Mo, Lei Yu, Jiyou Peng, Long Yang, Jiazhou Wang, Weigang Hu

{"title":"[Evaluation of Clinical Practicability of Hybrid Automatic Treatment Planning for Nasopharyngeal Carcinoma].","authors":"Enwei Mo, Lei Yu, Jiyou Peng, Long Yang, Jiazhou Wang, Weigang Hu","doi":"10.12455/j.issn.1671-7104.240159","DOIUrl":"10.12455/j.issn.1671-7104.240159","url":null,"abstract":"Objective: Automatic planning is a commonly used alternative to manual planning. This study evaluated the clinical performance of automatic plans available in commercial treatment planning systems for nasopharyngeal carcinoma (NPC) treatment by comparing automatic planning with manual planning.Methods: A total of 14 patients with nasopharyngeal carcinoma were enrolled in the study. For each patient, three different sets of clinical goals were used to generate three hybrid automatic plans based on 3D dose distribution prediction and three automatic plans based on script, respectively, which were compared with the manual plans used in clinic.Results: The dose coverage performance of the automatic planning based on 3D dose distribution prediction on the planning target volume (PTV) was comparable to that of the manual planning. Automatic planning based on 3D dose prediction achieved the level of manual planning in most organs at risk. However, automatic planning based on scripts did not perform well in the prediction of some organs at risk, especially the parotid gland.Conclusion: The hybrid automatic plan based on 3D dose distribution prediction can reach the level of manual planning and have good robustness with the change of clinical objective.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"55-60"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494786","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}

引用次数: 0

[Intelligent Monitoring System Based on Computer Vision and Artificial Intelligence]. [基于计算机视觉和人工智能的智能监控系统]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240287

Mingxi Zhang, Yirong Hong

{"title":"[Intelligent Monitoring System Based on Computer Vision and Artificial Intelligence].","authors":"Mingxi Zhang, Yirong Hong","doi":"10.12455/j.issn.1671-7104.240287","DOIUrl":"10.12455/j.issn.1671-7104.240287","url":null,"abstract":"To ensure the quality of care for inpatients in ophthalmic hospitals, address the complex and variable conditions of postoperative patients, and conduct more comprehensive, accurate and real-time monitoring of patients, an intelligent monitoring system based on computer vision and artificial intelligence has been designed. This system is employed for real-time monitoring of patient health conditions and intelligent care, with primary applications in medical monitoring, rehabilitation therapy, and inpatient care. It comprises intelligent data acquisition devices, smart cameras, continuous physiological data analysis algorithms, AI algorithms, and software. Given the complex and variable conditions of postoperative patients in ophthalmic hospitals, a comprehensive, accurate, and real-time monitoring of patients is required. Therefore, it is necessary to explore a monitoring technology that imposes low physiological and psychological burdens. The intelligent monitoring system can continuously collect patients' physiological parameter indicators and transmit the monitoring data to doctors' workstations or nurse stations after analysis using intelligent algorithms, providing new tools for patient monitoring, disease assessment, risk warning, and more. Furthermore, through the application of computer vision and artificial intelligence technologies, the system can analyze facial expressions, body postures, and other data to identify patients' emotional states and bedridden postures, enabling the timely detection of abnormal situations and implementation corresponding measures. This helps improving the daily work of medical staff, enhance the nursing safety in single-patient rooms in wards, and potentially find applications in the care of critically ill patients and elderly patients, thereby improving nursing efficiency and quality.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"74-79"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494788","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}

引用次数: 0

[Application Research of Extended NEH Algorithm Based on Flow Scheduling Problem in Discrete Scheduling Optimization of Medical Consumables]. [基于流调度问题的扩展NEH算法在医用耗材离散调度优化中的应用研究]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240178

Bin Liu, Tianying Wang, Yang Zhou

{"title":"[Application Research of Extended NEH Algorithm Based on Flow Scheduling Problem in Discrete Scheduling Optimization of Medical Consumables].","authors":"Bin Liu, Tianying Wang, Yang Zhou","doi":"10.12455/j.issn.1671-7104.240178","DOIUrl":"10.12455/j.issn.1671-7104.240178","url":null,"abstract":"Objective: Referring to the application of the NEH (Nawaz-Enscore-Ham) algorithm in flow shop scheduling, this paper proposes an optimization method of hospital medical consumables discrete scheduling based on the extended NEH algorithm, in order to obtain the optimal medical consumables discrete scheduling scheme and achieve the optimization of medical consumables discrete scheduling.Methods: Thoroughly analyze the scheduling needs of medical consumables in hospitals, predict the demand for medical consumables in each department. Construct a discrete scheduling optimization model for medical consumables and determine the constraint conditions for building the model (residual coefficient matrix, efficiency constraint matrix, and time window function). Then, solve the discrete scheduling optimization model for medical consumables based on the extended NEH algorithm.Results: By comparison the data before and after the experiment, it is found that the discrete scheduling time and cost of medical consumables in experimental departments have decreased to varying degrees, and all the differences are statistically significant ( P<0.05).Conclusion: Through experiments, it is known that the optimized medical consumables discrete scheduling scheme proposed meets the requirements of discrete scheduling time and cost, providing a better solution for hospital medical consumables discrete scheduling.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"67-73"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494748","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}

引用次数: 0

[Application Status of Machine Learning in Assisted Diagnosis Techniques of Cardiovascular Diseases]. [机器学习在心血管疾病辅助诊断技术中的应用现状]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240214

Pinliang Liao, Zihong Wang, Miao Tian, Hong Chai, Xiaoyu Chen

引用次数: 0

[Development of Non-Invasive Bi-Level Breathing Therapy System]. [无创双水平呼吸治疗系统的发展]。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.230421

Zhiying Yuan, Mingyue Li, Jieying Shan, Kai Wang, Jilun Ye, Xu Zhang

引用次数: 0

[Automatic Bone Fracture Reduction Technique with Section Registration]. 【自动骨折复位切片配准技术】。

中国医疗器械杂志 Pub Date : 2025-01-30 DOI: 10.12455/j.issn.1671-7104.240202

Qinhui Yuan, Mengxing Liu, Chu Guo, Yukun An, Ping Zhou

{"title":"[Automatic Bone Fracture Reduction Technique with Section Registration].","authors":"Qinhui Yuan, Mengxing Liu, Chu Guo, Yukun An, Ping Zhou","doi":"10.12455/j.issn.1671-7104.240202","DOIUrl":"10.12455/j.issn.1671-7104.240202","url":null,"abstract":"As a fundamental aspect of bone fracture treatment, fracture reduction plays a decisive role in restoring the structural integrity and function of bones. At present, fracture reduction techniques mostly rely on semi-automatic interaction methods or healthy-side bone templates for registration, which have many limitations in clinical practice. In order to enhance treatment efficiency and accuracy, an automatic fracture reduction algorithm is proposed. This algorithm utilizes the similarity of fracture cross-sections for registration, thereby reducing the workload of physicians and eliminating the need for a healthy-side bone template. Initially, the closed edge is identified and extracted by analyzing the differences in the fracture surface and the calorific value diagram of the roughness distribution. Next, the fracture section is determined by using the identified closed edge as a guideline for regional expansion and similarity matching. During the registration phase, the iterative closest point (ICP) algorithm is highly sensitive to distance. Therefore, the geometric features of point clouds are incorporated into the objective function of the registration algorithm to mitigate the influence of noise, and fracture section registration is implemented one by one. Finally, the algorithm is tested and compared on 180 simulated datasets and 16 publicly available datasets. The results show that the proposed algorithm significantly improves the registration accuracy, and the registration error of clinical bone fracture cases is controlled within 1.7 mm.","PeriodicalId":52535,"journal":{"name":"中国医疗器械杂志","volume":"49 1","pages":"1-7"},"PeriodicalIF":0.0,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143494759","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}

引用次数: 0