| A Bright Development for Over One Million Depression Patients

A groundbreaking new option is now available for the more than one million depression sufferers in South Korea—treatment accessible entirely via smartphone.

Digital therapeutic device specialist Hippo T&C (CEO: Tai-Myoung Chung) announced on the 15th that its depression treatment and management software, BlueKare—developed in collaboration with domestic and international medical experts—has been granted Class III approval by the Ministry of Food and Drug Safety (MFDS).

BlueKare is the first MFDS‑approved digital therapeutic device for depression in Korea. Globally, only one comparable product has obtained regulatory approval: ‘re:JOIN’, co-developed by Otsuka and Click Therapeutics, which has been cleared by the U.S. Food and Drug Administration (FDA).

CEO Tai-Myoung Chung said, “In a country that recorded 14,400 suicides in 2024 and holds the unfortunate distinction of the highest suicide rate among OECD nations, this announcement brings much‑needed good news for people struggling with depression.”

He added, “BlueKare is a prescription‑based mobile app delivering essential therapies for depression—including meditation, exercise, and CBT‑based conversational interventions—over an eight‑week treatment course.”

Founded in 2020 as a university‑based venture at Sungkyunkwan University’s Department of Software Engineering, Hippo T&C developed BlueKare with support from the Ministry of Trade, Industry and Energy. Medical experts from Samsung Seoul Hospital, National Rehabilitation Hospital, and Asan Medical Center contributed to the project.

Professor Hong‑Jin Jeon of Samsung Seoul Hospital’s Department of Psychiatry—who led the confirmatory clinical trial assessing safety and efficacy—remarked, “With clinical efficacy now proven, BlueKare is expected to play a significant role in future depression treatment.”

BlueKare is a CBT‑based emotional disorder treatment software in which users interact with a virtual “cyber dog” to relieve stress, reflect on their inner selves, and manage depressive symptoms in a safe, private environment—minimizing side effects and enabling usage anytime, anywhere. After domestic hospital deployment, Hippo T&C plans to launch in global markets including the U.S., Europe, Vietnam, and Singapore.

Digital medical devices—software or apps designed to support disease prevention, diagnosis, or treatment—are rapidly gaining traction. In the U.S., the sector is growing at an annual rate of 30.7%, and is expected to reach a market value of USD 17.3 billion (~KRW 22 trillion) by 2030.

Earlier this year, Hippo T&C introduced WithBuddy, a mental health product designed to prevent depression by detecting early signs of worry, anxiety, or stress. WithBuddy functions as a virtual pet companion—“Buddy”—with whom users converse, write encrypted emotional diaries, and receive CBT‑based support to strengthen their psychological resilience.

WithBuddy provides on‑demand conversational assistance via large language model (LLM), reducing the stigma and time commitment associated with in‑person counseling. A specialized AI model—trained on conversational data from groups such as firefighters, teachers, and high school students—can offer tailored support. For users needing additional help, the service will soon recommend human counselors.

Currently, WithBuddy is available as a workplace mental health management solution for enterprises, and as a counseling support tool in psychological counseling centers. Individual users can download it via Google Play or the Apple App Store.

Original Article : ETNEWS(https://www.etnews.com/20250613000068, Reporter Hyun-Min Kim)

This article is a translation of a Korean original into English.