ExaWizards’ Wholly Owned Subsidiary, ExaMD AI-Powered Dementia Diagnosis App Using Conversational Audio Designated as a Priority Review Product under Innovative Medical Device Program

ExaWizards Inc. (Minato-ku, Tokyo, Representative Director & President: Makoto Haruta; hereinafter, “ExaWizards”) is pleased to announce that an AI medical device that diagnoses dementia through conversational speech (hereinafter, “the Product”) being developed by our wholly owned subsidiary, ExaMD Inc. (Minato-ku, Tokyo, Representative Director: Koji Hazama; hereinafter, “ExaMD”) has been designated as a priority review product for programmed medical devices (SaMD: Software as Medical Device) by the Japanese Ministry of Health, Labor and Welfare.

On February 6, 2025, the Program Medical Device Investigation Committee of the Ministry of Health, Labour and Welfare’s Pharmaceutical Affairs and Food Sanitation Council reached a consensus on designating ExaMD’s product for priority review. Following this, the product was officially designated on February 7, 2025. This designation will enable us to be at the forefront of innovation, allowing us to use a more extensive consultation system and receive priority review in the processes leading up to early regulatory approval of the Product as a medical device on a global scale.

For detailed information, please refer to the press release dated February 7, 2025. https://exawizards.com/en/archives/29491/ 

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
Business: Industrial innovation and resolution of social issues via AI service development
URL: https://exawizards.com/en/

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