| Challenges and Insights from Clinical Trials of Imaging-based Artificial Intelligence Medical Device |
| 投稿时间：2021-12-29 修订日期：2022-02-24 Click here to download the full text |
| Citation of this paper:李静.医学影像类人工智能软件临床试验的挑战及启示[J].中国临床医学,0,(): |
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| Abstract:With China's imaging-based artifificial intelligence technology continues to advance , it is increasingly used as special medical devices to assist in diagnostic decision making.To ensure that the safety and effective of such medical devices placed on the market,clinical trials have become an important part of their pre-market quality verification.But there is still a lack of targeted clinical trial guidelines.In this paper, we briefly discuss the development status of imaging-based artifificial intelligence medical devices and the challenges in the clinical trial process, and try to explore the key points of trial quality management, so as to effectively manage risk, improve the quality of such clinical trials and promote the long-term development of the industry. |
| keywords:clinical trial, artificial intelligence,quality control |
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