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According to the Ministry of Food and Drug Safety (MFDS), the first digital therapeutics (DTx) product to get domestic marketing approval was Aimmed’s Somzz for treating insomnia. In the form of a smartphone application, Somzz is a software medical device that uses cognitive behavioral therapy (CBT) to treat insomnia. By improving sleep quality over a period of 6 to 9 weeks, the mobile app’s behavioral intervention, real-time feedback, and sleep habit training might reduce insomnia.

The MFDS evaluated the results of six-month clinical trials for Somzz conducted at three clinical trial institutions and concluded that the insomnia severity assessment scale was statistically improved after using the DTx device. In addition, the safety and effectiveness of the device were tested through scientific & thorough screening by a medical device committee.

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