{"title":"The status of the AI medical industry in China: A database and statistical analysis","authors":"Siwen Zhang , Zhe Huang , Guihong Feng , Xiaowen Yuan , Qi Zhang , Zicheng Wang , Yuwen Chen","doi":"10.1016/j.hlpt.2024.100889","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Artificial intelligence (AI) technology has developed rapidly in recent years, leading to exponential growth in the AI medical industry. However, a comprehensive investigation of approved medical devices in China is needed.</p></div><div><h3>Methods</h3><p>We utilized a web crawler to collect data on all medical devices from the China National Medical Products Administration website since 2018. Through natural language processing techniques and manual analysis, we identified all medical devices developed by artificial intelligence medical devices (AIMD) companies and conducted a statistical analysis.</p></div><div><h3>Results</h3><p>Since 2018, the number of AI-related medical devices approved in China has significantly increased. Most devices (79 %) were classified as Class II with moderate risk, whereas 21 % were classified as Class III with high risk. Most devices (74.2 %) were categorized as medical device software, and the most common application was medical image processing (63.2 %). In terms of target body areas, devices related to the heart accounted for the highest proportion (12.8 %), followed by those related to the lungs (11.3 %) and brain (6.7 %).</p></div><div><h3>Conclusion</h3><p>This study establishes a comprehensive database of medical devices developed by AIMD companies in China, enabling the public to gain a coherent understanding of their current development status.</p></div>","PeriodicalId":48672,"journal":{"name":"Health Policy and Technology","volume":"13 3","pages":"Article 100889"},"PeriodicalIF":3.4000,"publicationDate":"2024-07-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Health Policy and Technology","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2211883724000522","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"HEALTH POLICY & SERVICES","Score":null,"Total":0}
引用次数: 0
Abstract
Background
Artificial intelligence (AI) technology has developed rapidly in recent years, leading to exponential growth in the AI medical industry. However, a comprehensive investigation of approved medical devices in China is needed.
Methods
We utilized a web crawler to collect data on all medical devices from the China National Medical Products Administration website since 2018. Through natural language processing techniques and manual analysis, we identified all medical devices developed by artificial intelligence medical devices (AIMD) companies and conducted a statistical analysis.
Results
Since 2018, the number of AI-related medical devices approved in China has significantly increased. Most devices (79 %) were classified as Class II with moderate risk, whereas 21 % were classified as Class III with high risk. Most devices (74.2 %) were categorized as medical device software, and the most common application was medical image processing (63.2 %). In terms of target body areas, devices related to the heart accounted for the highest proportion (12.8 %), followed by those related to the lungs (11.3 %) and brain (6.7 %).
Conclusion
This study establishes a comprehensive database of medical devices developed by AIMD companies in China, enabling the public to gain a coherent understanding of their current development status.
期刊介绍：
Health Policy and Technology (HPT), is the official journal of the Fellowship of Postgraduate Medicine (FPM), a cross-disciplinary journal, which focuses on past, present and future health policy and the role of technology in clinical and non-clinical national and international health environments.
HPT provides a further excellent way for the FPM to continue to make important national and international contributions to development of policy and practice within medicine and related disciplines. The aim of HPT is to publish relevant, timely and accessible articles and commentaries to support policy-makers, health professionals, health technology providers, patient groups and academia interested in health policy and technology.
Topics covered by HPT will include:
- Health technology, including drug discovery, diagnostics, medicines, devices, therapeutic delivery and eHealth systems
- Cross-national comparisons on health policy using evidence-based approaches
- National studies on health policy to determine the outcomes of technology-driven initiatives
- Cross-border eHealth including health tourism
- The digital divide in mobility, access and affordability of healthcare
- Health technology assessment (HTA) methods and tools for evaluating the effectiveness of clinical and non-clinical health technologies
- Health and eHealth indicators and benchmarks (measure/metrics) for understanding the adoption and diffusion of health technologies
- Health and eHealth models and frameworks to support policy-makers and other stakeholders in decision-making
- Stakeholder engagement with health technologies (clinical and patient/citizen buy-in)
- Regulation and health economics
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