Abstract
It has been about 9 years since the Food and Drug Administration approved the first commercial CAD for mammography in the United States. Since then, several companies obtained approvals for lung CAD, CT lung CAD, Breast MRI CAD and CT colonoscopy CAD. On the other hand, only a few mammography CAD products obtained approvals from Ministry of Health, Labor and Welfare in Japan although the first CAD product was approved in Japan about two years after the first CAD was approved in the United States. This article describes about CAD approvals in the United States and also briefly summarizes clinical studies for PMA done by each CAD vendor. Please note that the information in this article is all public information and some of them may be obsolete.
