The Support Program for Screening of Depression / Rating of Severity, SWIFT (tentative name), jointly developed by the research group of Project Professor Taishiro Kishimoto of the School of Medicine, Keio University, Sumitomo Pharma and i2medical, was designated as a priority review item as Japan's first Software as a Medical Device (SaMD) by the Ministry of Health, Labour and Welfare (MHLW).
In recent years, the development of programmable medical devices using digital technology such as AI has become a global trend, but Japan lags in their development and practical application. MHLW introduced the SaMD priority‐review designation system on a trial basis in 2022. Priority review will be given to the SaMDs that meet the requirements for innovativeness, usefulness and willingness to develop and be applied in Japan before a global rollout. A public offering was made in September 2022, and three items were designated for the first time in March this year.
SWIFT is a system to assist in the detection and severity assessment of depressive episodes of depression or bipolar disorder. It firstly analyzes the patient's bioactivity and biometric data collected from a wristband‐type wearable device. Secondly, the system estimates depressive episodes defined by DSM5, the global diagnostic criteria for mental illness (such as depressed mood, decreased interest/pleasure, decreased appetite, insomnia, malaise, decreased energy and decreased ability to think/concentrate). Thirdly, it outputs the estimated score based on the Hamilton Depression Rating Scale. The group is developing medical devices to provide various information for doctors upon their diagnoses.
The Keio University School of Medicine is cooperating with many psychiatric hospitals and clinics to collect detailed clinical data. i2medical is constructing the optimal machine‐learning algorithm to judge the presence/absence of depressive episodes and to estimate their severity. Sumitomo Pharma is responsible for system development, clinical development, preparation for regulatory application and commercialization studies. The research team hopes to accelerate current ongoing clinical research, accumulate enough data and improve the estimation accuracy and plans to start clinical trials within three years.
This article has been translated by JST with permission from The Science News Ltd. (https://sci-news.co.jp/). Unauthorized reproduction of the article and photographs is prohibited.