English follows.

株式会社LIFESCAPES（本社︓東京都港区、代表取締役︓⽜場潤⼀、以下LIFESCAPES）が開発中の次世代治療⽤医療機器「（仮称）LIFESCAPES 治療⽤ BMI（Brain-Machine Interface）（以下、BMI）」が、2025年12⽉12⽇付で厚⽣労働⼤⾂より「先駆的医療機器」の指定を受けたことをお知らせします。本制度は、患者に世界で最先端の医療機器を最も早く提供することを⽬指したもので、厚⽣労働省が公表する「先駆的医療機器に指定された品⽬⼀覧」（令和7年12⽉12⽇時点）では、本品⽬は（R7先駆機）第2号として掲載されています。
https://www.mhlw.go.jp/content/11124500/001606945.pdf

本件に関するプレスリリースはこちらです。
https://prtimes.jp/main/html/rd/p/000000010.000140834.html

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LIFESCAPES’ Next-Generation Therapeutic BCI Designated as a “Pioneer Medical Device” by the Ministry of Health, Labour and Welfare

LIFESCAPES Inc. is pleased to announce that its next-generation therapeutic medical device currently under development, tentative name “LIFESCAPES Therapeutic BCI (Brain-Computer Interface),” was designated as a “Pioneer Medical Device” by the Minister of Health, Labour and Welfare on December 12, 2025.

The Pioneer Medical Device Designation System aims to provide patients in Japan with the world’s most advanced medical devices as quickly as possible. This product is listed as Item No. 2 in the “List of Designated Pioneer Medical Devices” published by the Ministry of Health, Labour and Welfare (as of December 12, 2025).

For more details, please refer to the MHLW announcement and our press release below:
MHLW List of Designated Pioneer Medical Devices (PDF):
https://www.mhlw.go.jp/content/11124500/001606945.pdf

Press Release(Japanese only):
https://prtimes.jp/main/html/rd/p/000000010.000140834.html