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 effects of different types of tricuspid regurgitation, implantation positions, and device models on the treatment outcomes of K-Clip for tricuspid regurgitation using numerical simulations. Methods     Three-dimensional reconstruction of the heart model was performed based on CT images. Two different regurgitation orifices were obtained by modifying the standard parameterized tricuspid valve leaflets and chordae tendineae. The effects of different K-Clip models at different implantation positions (posterior leaflet midpoint, anterior-posterior commissure, anterior leaflet midpoint, posterior septal commissure) were simulated using commercial explicit dynamics software Ls-Dyna. Conclusion     For the two types of regurgitation in this study, clipping at the posterior leaflet midpoint resulted in a better reduction of the regurgitation orifice (up to 75% reduction in area). Higher clamping forces were required for implantation at the anterior leaflet midpoint and posterior septal commissure, which was unfavorable for the smooth closure of the clipping components. There was no statistical difference in the treatment outcomes between the 18T and 16T K-Clip components, and the 16T component required less clamping force. Therefore, the use of the 16T K-Clip component is recommended.

[Objective]To explore the occurrence of gasdermin D(GSDMD)-mediated pyroptosis and its effect on cell proliferation,migration and tubular formation abilities of synovial vascular endothelial cells(VEC)in rheumatoid arthritis(RA).[Methods]Synovium tissues from knee joints of 22 RA patients and 18 orthopaedic arthropathies(Orth.A)patients were collected.The level of activated GSDMD-NT segment in synovium was detected by Western blot.The clinical characteristics of RA patients were compared between high and low synovial GSDMD-NT groups.The cell localization of GSDMD in RA synovium was detected by immunofluorescence staining.RA synovial fluid was added to the culture of human umbilical vein endothelial cells(HUVEC)in vitro,and the level of apoptosis and expression of pyroptosis pathway proteins were detected.The effects of GSDMD on apoptosis,proliferation,migration and tubule formation of HUVEC cells were analyzed.[Results]GSDMD expression in RA synovium was significantly higher than that in Orth.A,and more severe joint destruction and higher microvascular count score were found in RA patients with high GSDMD-NT expression.Synovial VEC had positive expression of GSDMD.Stimulation with RA synovial fluid could induce GSDMD-mediated pyroptosis in HUVEC,increased the secretion of vascular endothelial growth factor(VEGF)and their abilities of proliferation,migration and tubule formation.Knockdown of GSDMD could reverse the above effects.[Conclusion]GSDMD-mediated pyroptosis of partial synovial VEC aggravates RA joint destruction through VEGF secretion that promotes proliferation,migration and angiogenesis of the remaining VEC,which may be a new target to block neovascularization and inhibit joint destruction in RA.

Patients with severe trauma require an extremely timely treatment and transfusion plays an irreplaceable role in the emergency treatment of such patients. An increasing number of evidence-based medicinal evidences and clinical practices suggest that patients with severe traumatic bleeding benefit from early transfusion of low-titer group O whole blood or hemostatic resuscitation with red blood cells, plasma and platelet of a balanced ratio. However, the current domestic mode of blood supply cannot fully meet the requirements of timely and effective blood transfusion for emergency treatment of patients with severe trauma in clinical practice. In order to solve the key problems in blood supply and blood transfusion strategies for emergency treatment of severe trauma, Branch of Clinical Transfusion Medicine of Chinese Medical Association, Group for Trauma Emergency Care and Multiple Injuries of Trauma Branch of Chinese Medical Association, Young Scholar Group of Disaster Medicine Branch of Chinese Medical Association organized domestic experts of blood transfusion medicine and trauma treatment to jointly formulate Chinese expert consensus on blood support mode and blood transfusion strategies for emergency treatment of severe trauma patients ( version 2024). Based on the evidence-based medical evidence and Delphi method of expert consultation and voting, 10 recommendations were put forward from two aspects of blood support mode and transfusion strategies, aiming to provide a reference for transfusion resuscitation in the emergency treatment of severe trauma and further improve the success rate of treatment of patients with severe trauma.

Objective:To explore the clinical features and surgical outcomes of greater trochanteric fractures of the femoral neck in children.Methods:A retrospective study was conducted to analyze the 5 children with greater trochanteric fracture of the femoral neck who had been treated at Department of Pediatric Orthopaedics, Fuzhou Second General Hospital from January 2011 to December 2020. There were 1 boy and 4 girls, with an age of (11.0±1.9) years. By the Delbet classification, all were type Ⅲ fractures. The time from injury to operation was (4.4±2.1) days. The children were treated with cannulated screws (1 case) or fixation with a pediatric hip plate (4 cases). The clinical features of such fractures were analyzed; the fracture union time and hip function and complications at the last follow-up were recorded.Results:The clinical features of greater trochanteric fractures of the femoral neck in children were: (1) involvement of 2 anatomic sites in a narrow region, (2) comminuted fractures, and (3) all Delbet type Ⅲ fractures. The follow-up time was (22.8±6.0) months. All the 5 children obtained bony union. The union time was (5.2±1.8) weeks for greater trochanteric fractures, and 8.0 (8.0,10.0) weeks for femoral neck fractures. Follow-up observed no necrosis of the femoral head, premature closure of the femoral head epiphysis, hip varus deformity, or length disparity between the lower limbs. Premature closure of the greater trochanteric epiphysis occurred in 2 children after surgery. According to the Ratliff scoring, the hip function was excellent in 3 cases and good in 2.Conclusions:Greater trochanteric fractures of the femoral neck in children are a special kind of proximal femoral comminuted fractures that affect 2 anatomic sites in a narrow region and belong all to Delbet type Ⅲ fractures. Open reduction and internal fixation with cannulated screws or a pediatric hip plate is a safe and effective treatment for such fractures.

We report the successful treatment of mitral regurgitation by remote robotic transcatheter edge-to-edge repair(TEER)under pure transesophageal echocardiographic guidance in a 70-year-old male patient with severe mitral regurgitation due to ischemic cardiomyopathy.The patient showed no significant improvement after coronary interventional treatment and guideline-directed medical therapy before TEER.Following a multidisciplinary discussion,a TEER procedure was indicated and performed.The procedure utilized robotic assistance guided by echocardiography,combined with 5G communication technology,to remotely operate the surgical robot in Shenzhen from Beijing.Postoperatively,the patient's mitral regurgitation was reduced to trace,symptoms were markedly improved,there were no severe complications,and the patient was discharged five days after the operation.The integration of pure echo-guided interventional technology with remote robotic operation holds significant importance for enhancing the capabilities in treating cardiovascular diseases at the primary hospitals.