FRONTEO Inc. (Headquarters: Minato-ku, Tokyo; Representative Board of Director and President: Masahiro Morimoto; hereinafter referred to as FRONTEO) and Shionogi & Co., Ltd. (Headquarters: Chuo-ku, Osaka; Representative Board of Director and Chairman, President and CEO: Isao Teshirogi; hereinafter referred to as Shionogi) are pleased to announce that the AI ​​programmed medical device (SDS-881) for conversational cognitive function testing (neuropsychological testing), which they are jointly developing, has been designated as a priority review item by the Ministry of Health, Labor and Welfare's Programmed Medical Device Investigation Committee.

SDS-881 is a conversational cognitive function testing AI program medical device that can easily determine whether or not cognitive function has declined through free conversation. The results of the SDS-881 will be used to promote early diagnosis of dementia and treatment intervention. FRONTEO develops AI models and operates programs using its proprietary natural language processing AI engine "KIBIT," while Shionogi is responsible for clinical development, etc. Both companies will combine their respective strengths to promote smooth implementation in the medical field and acquisition of pharmaceutical approval in Japan, aiming to commercialize solutions based on high scientific evidence.

In this context, SDS-881 has been recognized for its innovativeness and medical usefulness, and was designated as a "programmed medical device priority review item" by the Ministry of Health, Labor and Welfare on February 2025, 2. Going forward, support for early approval, such as priority consultation, enhanced pre-evaluation, and the establishment of a concierge, is expected to be available, and the review period is expected to be significantly shortened. We believe that this will lead to the early implementation of support for cognitive function testing using advanced AI technology, contributing to rapid treatment and improved quality of life for patients.

Shionogi has set the SHIONOGI Group Vision of "Creating the future of healthcare with a new platform," and is aiming to transform into a "HaaS company" that provides comprehensive healthcare services while leveraging its strengths as a drug discovery-based pharmaceutical company. FRONTEO is engaged in research and development of various AI solutions equipped with KIBIT and their social implementation, and in the field of life sciences, it supports drug discovery research and medical activities through the analysis of scientific papers and medical data. Through this initiative, the two companies will expand new evaluation and diagnostic solutions that address unmet medical needs, including in the field of psychiatric and neurological disorders, and contribute to improving the quality of life of patients and their families.

■About Shionogi　URL:https://www.shionogi.com/jp/ja/
Shionogi is committed to “Contributing to a healthy and prosperous life” as our key focus. We will endeavor to deliver early diagnosis and treatment for the patients of psycho-neurological diseases, which still have high unmet medical needs, and contribute to improving the QOL of patients with psycho-neurological disorders and their families. To that end, we will strengthen our efforts, including collaboration with external partners.

■ About FRONTEO　URL:https://www.fronteo.com/
FRONTEO supports the judgment of experts in various fields who face social issues day and night through the provision of its proprietary specialized AI "KIBIT," and creates the starting point for innovation. Unlike general-purpose AI, our proprietary natural language processing technology (patented in Japan and the United States) enables high-speed and high-precision analysis without relying on the amount of training data or computing power. In addition, by utilizing patented technology that maps (visualizes the structure) the analyzed information, "KIBIT" can directly influence the insights of experts, and in recent years, KIBIT's technology has also been used in hypothesis generation and target discovery in drug discovery.
Through KIBIT's unique technology and approach, we aim to realize the philosophy of "providing solutions that do not overlook risks and opportunities buried in records, and realizing fairness in the information society." We are promoting social implementation in various fields of legal tech AI.
Founded in August 2003, listed on TSE Mothers (currently TSE Growth) on June 8, 2007. The company operates in Japan, the United States, South Korea, and Taiwan. Obtained a first-class medical device manufacturing and sales business license and registered a controlled medical device sales business. Capital: 6 yen (as of March 26, 898,618).

* FRONTEO and KIBIT are registered trademarks of FRONTEO in Japan.