ExaMD, a Member of the ExaWizards Group, obtained the Type II Medical Device Manufacturing and Marketing License, and the Medical Device Sales License - Empowering ExaMD to Develop, Manufacture, and Market Software as a Medical Device (SaMD)

NEWS

ExaMD Inc. (Minato-ku, Tokyo, Representative Director: Koji Hazama; hereinafter, “ExaMD”), a subsidiary of ExaWizards Inc., is pleased to announce that it has obtained the Type II Medical Device Manufacturing and Marketing license and the Medical Device Sales license from the Tokyo Metropolitan Government as of March 31, 2025. ExaMD is developing AI-powered SaMD, including software capable of diagnosing dementia after a one-minute conversation. This license will allow ExaMD to independently handle the entire process of developing, manufacturing, and marketing these innovative AI-driven medical devices.

ExaMD was established in February 2024 to provide specialized AI services to the healthcare and medical sectors and to develop and market AI-powered medical devices and healthcare solutions. The company is wholly owned by ExaWizards Inc., a leader in AI development.
ExaMD is currently developing an AI-powered ML-SaMD* that uses short, one-minute conversations via smartphone to determine the likelihood of dementia. In February 2025, the device was designated as a priority review item by Japan’s Ministry of Health, Labour and Welfare. With the recent acquisition of the Type II Medical Device Manufacturing and Marketing license, and the Medical Device Sales license, ExaMD has established a streamlined framework for independently managing the entire lifecycle of its SaMD products, from development to manufacturing and marketing. Leveraging this license and the priority review designation will allow ExaMD to accelerate their efforts to obtain regulatory approval at the earliest possible stage.
(*ML: Machine Learning)

☑ Licenses Acquired
Type II Medical Device Manufacturing and Marketing License (License No.: 13B2X1062)
Date Acquired: March 31, 2025

For more information about the SaMD currently under development by ExaMD, please refer to the details below:
ExaWizards’ Wholly Owned Subsidary, ExaMD  AI-Powered Dementia Diagnosis App Using Conversational Audio Gained Consensus on Priority Review Designation under Innovative Medical Device Program
https://exawizards.com/en/archives/29491/
ExaWizards Begins Development of an AI Medical Device (SaMD) to Diagnose Dementia Through Natural Conversation
https://exawizards.com/en/archives/24824/

ExaMD Company Profile
Company name: ExaMD Inc.
Location: 4-2-8 Shibaura, Minato-ku, Tokyo, 5F
Established: February 2024
Representative: Koji Hazama, Representative Director
Business: Planning, development, sales, and alliance of products and services using multi-modal AI technology to solve social issues related to healthcare
URL: https://examd.com/

ExaWizards Company Profile
Company name: ExaWizards Inc.
Location: 4-2-8 Shibaura, Minato-ku, Tokyo, 5F
Established: February 2016
Representative: Makoto Haruta, Representative Director, President & CEO
Business: Industrial innovation and resolution of social issues via AI service development
URL: https://exawizards.com/en/

＜Media Contact＞
ExaWizards Inc. Public Relations: publicrelations@exwzd.com