2020.06.15

Micron’s achievement related to novel coronavirus (COVID-19) infection

A programmed medical device powered by artificial intelligence (AI), developed with support from Micron, Inc. (Micron), has received the first approval in Japan as a “Pulmonary imaging analysis program related to novel coronavirus infection” on June 3rd, 2020.

 

Micron’s Clinical Development Support Department has been contracted by CES Descartes Co., Ltd. (Marketing Authorization Holders) (Manufactured by Beijing Infervision Technology Co., Ltd.) to perform the following: study protocol preparation, central imaging review organization, statistical analysis, documentation and whole application process support. We’re proud to have obtained PMDA approval at a remarkable speed of around two (2) months after contract execution.

 

In addition to contributing solutions to the novel coronavirus infection, providing support to the global social crisis, we will continue to enhance our regulatory approval support for medical devices equipped with AI, which are expected to grow in the future with the know-how obtained at this time.

 

CES Descartes Co., Ltd.

Obtained approval for a medical device for symptoms related to COVID-19 infection (http://desc.co.jp/covid-19/)

PMDA (https://www.pmda.go.jp/about-pmda/news-release/0012.html)

Ministry of Health, Labour and Welfare (https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/000011639.html)

 

If you have any questions regarding this announcement, please contact us at:

info@micron20230721.local