放射学中的人工智能:173种商用产品及其科学证据
Noa Antonissen1, Olga Tryfonos2, Ignas B Houben3
1Department of Medical Imaging, Radboud University Medical Center, Nijmegen, The Netherlands. noa.antonissen@radboudumc.nl.
European radiology
|July 24, 2025
概括
具有同行评审证据的放射性人工智能 (AI) 产品数量有所增加,但更高层次的证据仍然有限. 这表明市场增长,但强调了人工智能工具在现实世界中验证的挑战.
科学领域:
- 放射学 放射学是一门学科.
- 人工智能的人工智能
- 医疗器械评估 医疗器械评估
背景情况:
- 商用放射性人工智能 (AI) 产品的市场正在快速增长.
- 之前的审查评估了这些产品的证据基础.
- 了解证据的演变对于临床采用至关重要.
研究的目的:
- 评估2020年至2023年期间对CE认证放射性AI产品的同行评审证据的变化.
- 随着时间的推移,评估证据水平和研究设计特征.
- 为了确定AI在放射学中的验证趋势.
主要方法:
- 从2015年1月到2023年3月,对CE认证的放射性AI产品进行文献审查.
- 论文的分类基于有效性的层次模型 (技术准确性到社会经济影响).
- 分析研究特征,包括设计,供应商独立性和数据采购 (多中心/多国).
主要成果:
- 具有同行评审证据的CE认证人工智能产品数量从2020年的36%增加到2023年的66%.
- 诊断准确性研究 (第二级) 仍然占主导地位,从65%降至57%.
- 针对更高疗效水平 (3-6) 的研究保持不变 (~24%),尽管具有这种证据的产品数量从18%增加到31%.
- 多中心研究增加,但供应商独立性,跨国数据使用和前性设计下降.
结论:
- 放射性人工智能市场表现出成熟,同行评审证据增加.
- 持续关注效率较低的研究和减少供应商独立性带来了挑战.
- 需要进一步的研究,以建立公正的,现实世界的证据,以确保安全和有效的临床实施.
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