Speakers Introduction

I’m working as a reviewer of Software as a Medical Device (SaMD) in Pharmaceuticals and Medical Device Agency (PMDA). I’m in charge of computer-aided diagnosis (CAD) that utilize AI technology and products that analyze the results of genetic testing and contributes to the prediction of drug efficacy and the determination of the optimal treatment strategy. I also have experience in reviewing medical devices used in the field of gastroenterology and urology, including robotic surgical devices and colon stents. In addition, I represent Japan as a member of the AI Working Group of the International Medical Device Regulatory Forum (IMDRF).

Previously, I was a research associate at Waseda University, where I studied AI-based medical device regulation and earned Ph.D. I continue to lecture to graduate students as a part-time lecturer at Waseda University and as a visiting associate professor at Hiroshima University.