The objective of this study is to map the global scientific competitive landscape in the field of artificial intelligence (AI) medical devices using scientific data. A bibliometric analysis was conducted using the Web of Science Core Collection to examine global research trends in AI-based medical devices. As of the end of 2023, a total of 55 147 relevant publications were identified worldwide, with 76.6% published between 2018 and 2024. Research in this field has primarily focused on AI-assisted medical image and physiological signal analysis. At the national level, China (17 991 publications) and the United States (14 032 publications) lead in output. China has shown a rapid increase in publication volume, with its 2023 output exceeding twice that of the U.S.; however, the U.S. maintains a higher average citation per paper (China: 16.29; U.S.: 35.99). At the institutional level, seven Chinese institutions and three U.S. institutions rank among the global top ten in terms of publication volume. At the researcher level, prominent contributors include Acharya U Rajendra, Rueckert Daniel and Tian Jie, who have extensively explored AI-assisted medical imaging. Some researchers have specialized in specific imaging applications, such as Yang Xiaofeng (AI-assisted precision radiotherapy for tumors) and Shen Dinggang (brain imaging analysis). Others, including Gao Xiaorong and Ming Dong, focus on AI-assisted physiological signal analysis. The results confirm the rapid global development of AI in the medical device field, with "AI + imaging" emerging as the most mature direction. China and the U.S. maintain absolute leadership in this area-China slightly leads in publication volume, while the U.S., having started earlier, demonstrates higher research quality. Both countries host a large number of active research teams in this domain.
Artificial Intelligence ; Bibliometrics ; Humans ; China ; Equipment and Supplies ; United States ; Biomedical Research

The emergence of new-generation artificial intelligence technology has brought numerous innovations to the healthcare field, including telemedicine and intelligent care. However, the artificial intelligent medical device sector still faces significant challenges, such as data privacy protection and algorithm reliability. This study, based on invention patent analysis, revealed the technological innovation trends in the field of artificial intelligent medical devices from aspects such as patent application time trends, hot topics, regional distribution, and innovation players. The results showed that global invention patent applications had remained active, with technological innovations primarily focused on medical image processing, physiological signal processing, surgical robots, brain-computer interfaces, and intelligent physiological parameter monitoring technologies. The United States and China led the world in the number of invention patent applications. Major international medical device giants, such as Philips, Siemens, General Electric, and Medtronic, were at the forefront of global technological innovation, with significant advantages in patent application volumes and international market presence. Chinese universities and research institutes, such as Zhejiang University, Tianjin University, and the Shenzhen Institute of Advanced Technology, had demonstrated notable technological innovation, with a relatively high number of patent applications. However, their overseas market expansion remained limited. This study provides a comprehensive overview of the technological innovation trends in the artificial intelligent medical device field and offers valuable information support for industry development from an informatics perspective.
Artificial Intelligence ; Patents as Topic ; Humans ; Inventions ; China ; Brain-Computer Interfaces ; Telemedicine ; Equipment and Supplies ; Robotics ; Algorithms

The rapid development of artificial intelligence technology is driving profound changes in medical practice, particularly in the field of medical device application. Based on data from the U.S. clinical trials registry, this study analyzes the global registration landscape of clinical trials involving artificial intelligence-based medical devices, aiming to provide a reference for their clinical research and application. A total of 2 494 clinical trials related to artificial intelligence medical devices have been registered worldwide, with participation from 66 countries or regions. The United States leads with 908 trials, while for other countries or regions, including China, each has fewer than 300 trials. Germany, the United States, and Belgium serve as central hubs for international collaboration. Among the sponsors, 63.96% are universities or hospitals, 22.36% are enterprises, and the remainder includes individuals, government agencies and others. Of all trials, 79.99% are interventional studies, 94.67% place no restrictions on participant gender, and 69.69% exclude children. The targeted diseases are primarily neurological and mental disorders. This study systematically reveals the global distribution characteristics and research trends of artificial intelligence medical device clinical trials, offering valuable data support and practical insights for advancing international collaboration, resource allocation, and policy development in this field.
Artificial Intelligence ; Humans ; Clinical Trials as Topic/statistics & numerical data* ; Equipment and Supplies ; Registries ; United States

In recent years, the research on artificial intelligence medical devices has risen markedly along with the expanding application scenarios, exhibiting prominent interdisciplinary characteristics. From 2000 to 2024, the variety of research in artificial intelligence medical devices has significantly increased, while the balance of disciplines has slightly declined, and Simpson's diversity index has continuously increased. Medicine and biology are the main research themes and supportive disciplines in this field. Knowledge from computer science, engineering technology, and mathematics is widely involved and shows an upward trend, while content from the humanities and social sciences is less involved in the research. Compared to the United States and the United Kingdom, China has relatively less biological and chemical knowledge content in the research of this field, but more content related to computer science, engineering technology and material science is involved. This study analyzes the current state and trends of interdisciplinary on artificial intelligence medical devices from the perspective of macro-categories of disciplines, aiming to provide references for research planning, talent training and interdisciplinary cooperation in the field.
Artificial Intelligence ; Humans ; Equipment and Supplies ; Interdisciplinary Research

[摘 要] 目的：探究高迁移率族蛋白B1（HMGB1）中和抗体对肺癌LLC细胞移植瘤模型小鼠放疗联合PD-1抑制剂致放射性肺损伤的影响。方法: 实验用25只雄性C57BL/6小鼠，随机分为对照组、PD-1抑制剂组、放疗组、放疗 + PD-1抑制剂组及HMGB1中和抗体 + PD-1抑制剂 + 放疗组，每组5只。向每只动物的右腿皮下移植肺癌LLC细胞作为原发肿瘤，间日左腿皮下移植LLC细胞作为继发肿瘤。实验第28天处死动物取肺组织和移植瘤，用H-E、Masson染色观察肺组织病理变化情况，免疫组织化学法检测肺组织和移植瘤组织中CD4+和CD8+ T淋巴细胞浸润情况，酶联免疫吸附实验（ELISA）检测肺组织中TNF‐α、TGF-β和IL-6的表达。结果: 与对照或PD-1抑制剂组比较，其他3组小鼠移植瘤体积明显缩小（P < 0.01或P < 0.001），HMGB1中和抗体不能使移植瘤体积进一步缩小；与对照或PD-1抑制剂组比较，其他3组小鼠肺组织的炎症评分和胶原容积分数（CVF）均明显增加（P < 0.05、P < 0.01、P < 0.001或P < 0.000 1），HMGB1中和抗体可部分抑制放疗的不良反应（P < 0.01或P < 0.001）；与对照或PD-1抑制剂组比较，其他3组肺组织中CD4+ T淋巴细胞浸润明显增多（均P < 0.001），HMGB1中和抗体可部分抑制肺组织中CD4+ T淋巴细胞浸润（P < 0.01）；与对照或PD-1抑制剂组比较，其他3组移植瘤组织中CD4+ 、CD8+ T淋巴细胞浸润明显增加（均P < 0.001），HMGB1中和抗体不能抑制移植瘤组织中T细胞的浸润。与对照或PD-1抑制剂组比较，其他3组肺组织中IL-6表达升高，TGF-β表达下降（均P < 0.05），HMGB1中和抗体对肺组织中TNF-α、IL-6和TGF-β表达无明显影响。结论: HMGB1中和抗体不影响对移植瘤生长抑制的前提下，可能通过减少肺部炎性细胞的浸润，进而减轻肺部炎性损伤及纤维化。

Objective To investigate the clinical efficacy of Xiaozhi Tea(composed of Eupatorii Herba,Nelumbinis Folium,Chrysanthemi Flos,Cassiae Semen,Crataegi Fructus,bran-fried Atractylodis Macrocephalae Rhizoma,Poria,Pseudostellariae Radix,Citri Reticulatae Pericarpium,Glycyrrhizae Radix et Rhizoma Praeparata cum Melle)combined with Atorvastatin Calcium Tablets for the treatment of hyperlipidemia patients with turbid phlegm obstruction syndrome.Methods A retrospective cohort study was conducted in 200 hyperlipidemia patients with turbid phlegm obstruction syndrome who visited the outpatient department of Shenzhen Bao'an Traditional Chinese Medicine Hospital Group from September 2023 to September 2024.The patients were equally divided into a trial group and a control group based on the treatment regimen,with 100 cases in each group.The control group received oral use of Atorvastatin Calcium Tablets alone,while the trial group received Xiaozhi Tea in addition to Atorvastatin Calcium Tablets orally,both groups were treated for 8 weeks.Changes in traditional Chinese medicine(TCM)syndrome scores and lipid profiles of total cholesterol(TC),triglycerides(TG),high-density lipoprotein cholesterol(HDL-C),and low-density lipoprotein cholesterol(LDL-C)in the two groups were observed before and after treatment.After treatment,the clinical efficacy and safety of the two groups were evaluated.Results(1)There were 3 patients in the control group dropping out due to lack of follow-up data,leaving 197 patients who eventually completed the study,100 cases in the trial group and 97 cases in the control group.(2)After 8 weeks of treatment,the total effective rate in the trial group was 97.00%(97/100)and that in the control group was 87.63%(85/97).The intergroup comparison(tested by chi-square test)showed that the trial group showed significantly stronger efficacy than the control group(P＜0.05).(3)Both groups exhibited significant reductions in TCM syndrome scores after treatment in comparison with those before treatment(P＜0.05),and a more pronounced reduction was presented in the trial group(P＜0.05).(4)Both groups showed decreased TC,TG,and LDL-C levels(P＜0.05)and increased HDL-C level after treatment in comparison with those before treatment(P＜0.05).The trial group demonstrated more obvious reduction of TC,TG,LDL-C,and more obvious elevation of HDL-C than the control group(P＜0.05).(5)In terms of safety,no severe adverse reactions occurred in either group.The incidence of adverse reactions in the trial group was 1.00%(1/100)and that in the control group was 2.06%(2/97),with no statistically significant difference between groups(P＞0.05).Conclusion Xiaozhi Tea combined with Atorvastatin Calcium Tablets exerts certain efficacy in treating hyperlipidemia with turbid phlegm obstruction syndrome,and is effective on significantly improving lipid profiles and clinical symptoms.The combination therapy demonstrates superior efficacy compared to Atorvastatin Calcium Tablets alone.

Objective:In critical care medicine, extubation is a pivotal step in the management of mechanically ventilated patients. Accurately determining the optimal timing for extubation is essential for minimizing complications and improving patient survival rates. However, reliable indicators to predict clinical outcomes following extubation remain scarce. This study aims to identify a novel and robust predictor of extubation success in critically ill patients, thereby providing clinicians with more precise decision-making support.Methods:This retrospective study analyzed data from adult patients who underwent mechanical ventilation and were evaluated for extubation across six intensive care units (ICUs) at Xiangya Third Hospital of Central South University between January 2019 and December 2021. Patients with a history of difficult airway, upper airway obstruction, or neuromuscular disorders affecting respiratory function were excluded. The primary outcome was the reintubation rate within 24 hours post-extubation. Categorical variables were analyzed using the chi-square test or Fisher’s exact test, while between-group differences were assessed with the Mann-Whitney U test. Significant predictors identified in univariate analysis were further evaluated via multivariate logistic regression. The diagnostic accuracy of the maximum inspiratory pressure/body mass index (MIP/BMI) ratio was determined using receiver operating characteristic (ROC) curve analysis, with the Youden index employed to establish the optimal cutoff value. Kaplan-Meier analysis and log-rank tests were used to compare extubation success rates between groups. Statistical analyses were performed using SPSS V28.0 and Stata v.16.0. Results:Diabetes comorbidity ( OR: 8.181, 95% CI: 1.659–40.338) and MIP/BMI ( OR: 0.140, 95% CI: 0.042–0.469) were identified as independent predictors of reintubation. The area under the ROC curve (AUROC) for MIP/BMI was 0.753, demonstrating good predictive accuracy. The optimal cutoff value for MIP/BMI was 1.26 cmH 2O/(kg·m 2), with a sensitivity of 55.3% and specificity of 92.3%. Kaplan-Meier analysis revealed a significantly higher reintubation rate in the low MIP/BMI group compared to the high MIP/BMI group ( P = 0.009), further validating its predictive utility. Conclusions:This study establishes MIP/BMI as a novel and clinically valuable predictor of extubation outcomes in critically ill patients. A cutoff value of 1.26 cmH 2O/(kg·m 2) was found to best predict successful extubation.

BACKGROUND:The addition of traditional rod-rod fixation for atlantoaxial joint disease to C1-C2 pedicle screw-rod fixation(C1-C2 PSR)can provide stronger anti-rotation stability for screw/rod fixation,but there is a risk of installation difficulties,impact on bone graft bed,and spinal cord injury.The new horizontal screw-screw crosslink(hS-S CL)designed by the authors can effectively overcome the above shortcomings,but its biomechanical properties are unclear. OBJECTIVE:To analyze biomechanical properties of new horizontal screw-screw crosslink in C1-C2 PSR by three-dimensional finite element analysis. METHODS:CT thin layer scanning data were collected from the occipital base to the axis(C0-2)of one adult healthy male volunteer.The atlantoaxial finite element models were established respectively:the normal group,the unstable group,the non-crosslink group(unstable+C1-C2 PSR),and the crosslink group(C1-C2 PSR+hS-S CL).Range of motion and Von Miss Stresses in flexion and extension,lateral flexion and rotation of the four groups were calculated by applying 1.5 Nm torque to each finite element model,and the stress cloud was extracted. RESULTS AND CONCLUSION:(1)Range of motion of the unstable group was increased by 43.8%-78.7%compared with the normal group,and the range of motion of the internal fixation groups was 90.2%-98.7%lower than that of the unstable group under six conditions.The range of motion of the crosslink group and the non-crosslink group was basically the same in flexion and extension states,but in lateral flexion and rotation states,the range of motion of the crosslink group decreased 34.3%-43.8%and 78.6%-79.1%,respectively,compared with the non-crosslink group,and range of motion decreased most obviously in rotation state.(2)The stress peak of the internal plant model:The maximum stress of the crosslink group was generally smaller than that of the non-crosslink group,and the stress peak value of all the internal fixation groups was the lowest when the extension was carried out.(3)The stress cloud of internal plants showed that there was no obvious stress concentration phenomenon in the internal fixation,and the main stress distribution areas were the screw root and bone joint,and the crosslink ends were the screw tail groove or the joint rod joint.(4)The new horizontal screw-screw crosslink can obviously improve the anti-rotation stability of internal fixation and it can share part of the pressure in the three-dimensional motion direction of the internal fixation system and reduce the maximum stress of the internal plants.However,the stress distribution is obvious at both ends of the crosslink,and this part may be prone to fracture of the crosslink.

BACKGROUND:Posterior atlantoaxial pedicle screw rod internal fixation is the main method for treating atlantoaxial dislocation,and the horizontal crosslink plays an important role in the antirotation ability of the internal fixation system.The new horizontal screw-screw crosslink can effectively overcome the disadvantages of traditional horizontal crosslink,such as inconvenient installation,impact on bone grafting bed,and potential spinal cord injury.However,the biomechanical properties of the new horizontal screw-screw crosslink with different installation modes are still unclear. OBJECTIVE:To investigate the biomechanical characteristics of new different installation modes of horizontal screw-screw crosslink in the C1-C2 pedicle screw-rod fixation and to provide a theoretical basis for optimal installation mode. METHODS:Six fresh human occipitocervical specimens were divided into the intact state group(group A),and the atlantoaxial instability model of type Ⅱ odontoid fracture was established based on the intact state group as the instability group(group B).The C1-C2 pedicle screw-rod fixation was performed on each specimen based on the instability group(group C).In group C,different installation modes of horizontal screw-screw crosslink were successively installed in each specimen,including upper transverse connection(two atlas screw tails)as group D,lower transverse connection(two axis screw tails)as group E,diagonal transverse connection(upper left and lower right for group F,lower left and upper right for group G),and cross transverse connection as group H.The specimen models were tested in order of flexion,extension,lateral flexion and lateral rotation on a three-dimensional motion machine,and the atlantoaxial range of motion of each group of specimens was obtained.Repeated measure analysis of variance was used to evaluate the biomechanical properties of each group. RESULTS AND CONCLUSION:(1)Under six states,the range of motion of groups A,C,D,E,F,G and H was smaller than that of group B,and there were statistically significant differences(P＜0.05).(2)In the flexion and extension states,there was no significant difference among the five types of horizontal screw-screw crosslink groups(P＞0.05).(3)In the left and right rotation directions,there were significant differences in D and E groups compared with F,G and H groups(P＜0.05);there were no significant differences between D and E groups,and F and G groups(P＞0.05),and there were no significant differences in F and G groups compared with H group(P＞0.05).(4)In conclusion,under flexion-extension states,the biomechanical stability of five types of horizontal screw-screw crosslink groups was similar,but under the rotation state,the stability of diagonal horizontal screw-screw crosslink group and cross horizontal screw-screw crosslink group was obviously better than that of transverse horizontal screw-screw crosslink group;however,the stability of diagonal horizontal screw-screw crosslink group is similar to the cross horizontal screw-screw crosslink group,so the former is more worthy of clinical recommendation.

BACKGROUND:The pedicle navigation template has many advantages,but there are still some problems.For example,poor soft tissue dissection leads to poor adhesion of the pedicle navigation template,resulting in screw path deviation;careful dissection of soft tissue to fit the pedicle navigation template leads to prolonged surgery time and increased bleeding;the design of the pedicle navigation template cannot predict the vertebral rotation and the impact of body position changes,resulting in the poor fitting. OBJECTIVE:To explore the utility of a new 5-point positioning point-contact pedicle navigation template in the case of scoliosis and complex pedicle. METHODS:A total of 20 patients with scoliosis and complicated pedicle admitted to the Department of Spinal Surgery,Guizhou Hospital,Beijing Jishuitan Hospital from February 2020 to February 2023 were selected for scoliosis orthopedics.During the operation,the 5-point positioning point-contact pedicle navigation template was used to guide the screws.According to the inclusion and exclusion criteria,34 cases were matched as the empirical nail placement group,and conventional barehanded nail placement was performed.The time of placement,the amount of bleeding,the number of fluoroscopies,the number of manual diversions,the level and accuracy of pedicle screws,the complications of placement,and the rate of correction of main curvature were compared between the two groups. RESULTS AND CONCLUSION:(1)There were no significant differences in sex,age,coronal Cobb's angle of the main curvature,bending Cobb's angle of the main curvature,pedicle variation,apex rotation,fusion segment,number of screws,level of screws,accuracy of screws,and rate of correction of main curvature between the navigation template group and the empirical nail placement group(P>0.05).(2)Compared with the empirical nail placement group,the navigation template group had more advantages in time of placement(P=0.034),amount of bleeding(P=0.036),number of fluoroscopies(P=0.000)and number of manual diversions(P=0.021).(3)There were 0 cases of screw-related complications in both groups.(4)In conclusion,the 5-point positioning point-contact 3D printing pedicle navigation template has a claw-like structure.It can firmly adapt to various deformities of the lamina articular process,avoid drift,and accurately place the screws.It has a point-like contact lamina structure to avoid extensive and complete dissection of the posterior structure,and reduce bleeding,operation time,and trauma.Pre-designed screw entry points and directions can reduce the number of fluoroscopy and operation time.Segmental design can avoid discomfort due to changes in anesthesia position.The operation is simple and the accuracy of screw placement is high.