基于人工智能的医疗器械用于糖尿病视网膜病的查在欧盟
Andrzej Grzybowski1,2, Kai Jin3,4
1Department of Ophthalmology, University of Warmia and Mazury, 10-719, Olsztyn, Poland. ae.grzybowski@gmail.com.
Ophthalmology and therapy
|January 30, 2026
概括
对于糖尿病视网膜病变 (DR) 检测的人工智能 (AI) 系统在欧洲表现和实施准备程度各不相同. 为了确保安全部署,需要进行进一步的研究,以获得一致的报告和现实世界的有效性.
科学领域:
- 眼科医生 眼科 眼科
- 医疗成像医学成像
- 人工智能的人工智能
背景情况:
- 糖尿病视网膜病变 (DR) 是可预防的失明的主要原因.
- 欧洲查计划面临着劳动力和能力方面的挑战.
- 人工智能为可扩展的DR检测提供了潜力,但具有可变的监管地位和验证.
研究的目的:
- 在欧盟审查CE认证的AI系统用于DR检测.
- 绘制有关监管地位,验证和实施准备情况的证据.
- 为了识别人工智能驱动的DR查的证据缺口.
主要方法:
- 对13个经过CE认证的AI系统用于DR检测的范围审查.
- 在设备名称,分类,证据,验证,性能和实施上绘制的数据.
- 专注于2025年10月23日起在欧盟可用的系统.
主要成果:
- 大多数人工智能系统都使用深度学习进行基底图像分析,并进行自动化质量评估.
- 报告的可参考DR (RDR) 的敏感性/特异性各不相同,但通常符合预期;异质性限制了比较.
- 对视力威胁性DR (STDR) 检测的证据较少,变化更大;实施数据有限.
结论:
- 用于DR检测的CE认证AI是多样化和不断发展的.
- 在监管和验证方面取得了进展,但STDR和实施的证据异质.
- 未来的研究应侧重于一致的标准,多式联运方法和欧盟MDR合规的现实有效性.
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