Analysis of the global registration status of clinical trials for artificial intelligence medical device.
10.7507/1001-5515.202408035
- Author:
Yan LU
1
;
Juan CHEN
1
;
Ting ZHANG
1
;
Shu YAN
1
;
Dongzi XU
1
;
Zhaolian OUYANG
1
Author Information
1. Institute of Medical Information, Chinese Academy of Medical Sciences, Beijing 100020, P. R. China.
- Publication Type:Journal Article
- Keywords:
Artificial intelligence medical device;
Bibliometric analysis;
Clinical research trends;
Clinical trial;
International collaboration
- MeSH:
Artificial Intelligence;
Humans;
Clinical Trials as Topic/statistics & numerical data*;
Equipment and Supplies;
Registries;
United States
- From:
Journal of Biomedical Engineering
2025;42(3):512-519
- CountryChina
- Language:Chinese
-
Abstract:
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.
