人工智能心电分析软件审评关注点研究

Research on the Focus of the Review of Artificial Intelligence ECG Analysis Software

分析心电产品的产品注册现状,基于当前心电自动分析诊断软件的审评要求,从产品监管信息要求、产品性能研究、软件研究资料要求、临床评价要求等方面提出人工智能心电分析软件的基本审评关注点,为人工智能心电厂家提供注册申报参考。

This paper analyzes the current product registration status of ECG products,and proposes artificial intelligence ECG analysis from the aspects of product regulatory information requirements,product performance research,software research data requirements,and clinical evaluation requirements based on the current review requirements for ECG automatic analysis and diagnosis software.The basic review focus of the software provides registration and application reference for artificial intelligence ECG manufacturers.