Regulatory Science of Medical Products
Online ISSN : 2189-0447
Print ISSN : 2185-7113
ISSN-L : 2185-7113
Regulatory Trend of FDA in AI-based Computer-aided Detection/Diagnosis (AI-CAD) System
Hiroshi FUJITA
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JOURNAL FREE ACCESS

2019 Volume 9 Issue 1 Pages 37-42

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Abstract

In 2018, in the computer-aided detection/diagnosis (CAD) system for medical images, it was a year commemorating the 20th anniversary of commercialization in the United States. Twenty years have passed, and especially with the development of deep learning technology in AI (artificial intelligence), CAD has evolved and diversified as AI-CAD. Along with that, the FDA has also undergone a change in the review status of CAD and its related areas. This article will touch on part of the current situation.

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© 2019 Society for Regulatory Science of Medical Products
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