South Korea’s domestic digital therapeutics market is expanding rapidly beyond insomnia to treat clinical depression, attention-deficit/hyperactivity disorder (ADHD), and developmental disorders, according to data provided by the Ministry of Food and Safety (MFDS) to Medi:Gate News. As software-driven medical devices gain regulatory approval, the clinical landscape for digital health is shifting toward structured, application-based interventions.
Data provided by the Ministry of Food and Safety to Medi:Gate News shows that a total of 17 digital therapeutics had received regulatory approval as of July 28. The approvals span a timeline beginning with two devices in 2023, two in 2024, ten in 2025, and three additional approvals recorded in the first half of the year.
This expansion follows a global growth trajectory within the sector. According to projections by market research firm Grand View Research cited by Medi:Gate News, the global digital therapeutics market is anticipated to expand from 95억달러 in 2025 to 120억달러 in 2026, eventually reaching 752억달러 by 2033, with an expected compound annual growth rate of 30.0% between 2026 and 2033.
Regulatory Approvals Target Depression, Temporomandibular Disorders, and Developmental Challenges
The regulatory approvals issued during the first half of the year comprise three distinct software medical devices addressing mental health and physical rehabilitation. In February, Mind’s AI secured approval for “CHEEU. Forest N,” a virtual reality-based digital therapeutic designed to improve depressive symptoms in patients with depressive disorders, as reported by Medi:Gate News. The program incorporates mentalization-based treatment and dialectical behavior therapy, guiding patients through psychiatric evaluations, educational modules, and structured training sessions inside a virtual environment.
In April, Dwave received approval for “Clicksound,” a software medical device intended for the treatment of temporomandibular joint disorders. The device utilizes artificial intelligence-based facial analysis technology to formulate customized rehabilitation plans, helping patients manage pain and restore jaw function over a six-week regimen. Subsequently, in May, Newdive obtained authorization for “buddy-in,” a mobile digital therapeutic aimed at children and adolescents aged 10 to 18 diagnosed with autism spectrum disorder or social communication disorders. The program translates traditional cognitive behavioral therapy and social skills training into a game-like digital format across 30 sessions over six weeks.
Diversification of Therapeutic Modalities and Target Indications
While the domestic market initially focused on mobile implementations of cognitive behavioral therapy for insomnia—such as Aimnext’s “Somzz” and Welto’s “SleepQ”—regulatory filings demonstrate a broadening array of technical modalities. Current approved devices incorporate mobile applications, virtual reality, gamified cognitive training, rehabilitation exercises, and behavioral modification tools.
Multiple products now exist within several target categories. In the insomnia segment, Somzz and SleepQ share the market. Mild cognitive impairment treatments include “Cogthera” and “Superbrain DEX,” while temporomandibular disorder devices comprise “Clickless DTx” and Clicksound. Within the depressive disorder sector, CHEEU. Forest N joins “BlueKare-T,” illustrating a growing diversification of software-based medical interventions available to clinicians and patients.
The proliferation of digital therapeutics addresses structural limitations in traditional clinical settings, where chronic conditions like insomnia and behavioral disorders often encounter barriers regarding time, cost, and specialized personnel shortages. For instance, cognitive behavioral therapy for insomnia is recommended as a first-line treatment for chronic insomnia, yet delivering it consistently in standard practice remains challenging.
Clinical data for early approved devices demonstrate sustained therapeutic outcomes. A multicenter, single-blind, randomized controlled trial of Somzz showed improvements in insomnia severity, sleep efficiency, wake time after sleep onset, and sleep satisfaction, with effects maintained at a three-month follow-up evaluation. As the MFDS continues to clear software medical devices across broader therapeutic areas, researchers and clinicians are monitoring how these digital tools integrate into routine hospital workflows and insurance reimbursement frameworks.
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