NMPA premarket application experience for a computer aided diagnosis software using fundus images of diabetic retinopathy
Journal Title: Eye Science (Yanke Xuebao) - Year 2021, Vol 36, Issue 1
Abstract
Based on the NMPA premarket application through two and a half years for the computer aided diagnosis software using fundus images of diabetic retinopathy, which is an innovative medical device of Shanghai EagleVision Medical Technology Co., Ltd. (Airdoc), this article introduced the development process, the premarket application, and the key points in the application of this artificial intelligence device, also lists the related regulations and guidelines as references to provide some ideas for the follow-up premarketing application of such kind of products.
Authors and Affiliations
Xiaoli CAO, Yuzhong CHEN
Keywords
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- EP ID EP763472
- DOI 10.3978/j.issn.1000-4432.2021.01.17
- Views 21
- Downloads 0
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