Welt gets second digital therapeutic device approval in S. Korea

South Korea's Ministry of Food and Drug Safety announced on Wednesday that it has approved the cognitive therapy software "WELT-I" developed by Welt Corporation as the second domestic digital therapeutic device.

Digital therapeutic devices are software-based medical devices that provide evidence-based therapeutic interventions to patients for the prevention, management, and treatment of medical disorders or diseases.

WELT-I is a software medical device implemented as a mobile app that aims to intervene in psychological, behavioral and cognitive factors that perpetuate or exacerbate insomnia, and it has been approved for use in improving the symptoms of insomnia patients by increasing sleep efficiency.

According to the ministry, this product provides personalized appropriate sleep times based on sleep diary data entered by the patient and analyzes sleep-disruptive habits to improve insomnia in the patient over a period of six to eight weeks.

The ministry stated that it established a "Medical Device Committee" composed of experts in neuropsychiatry and digital therapy from the Korean Neuropsychiatric Association and the Korean Society for Digital Therapy, among others, to review the safety and efficacy of WELT-I through consultation and evaluation.

In February of this year, the ministry approved Aimmed's insomnia digital therapeutic device "Somzz" as the first domestic digital therapeutic device.

Welt Corporation is a digital healthcare startup spun off from Samsung Electronics Co. in 2016. In 2021, Welt signed an equity investment and partnership with Handok Pharmaceuticals, and Handok currently holds the domestic distribution rights for WELT-I.

Write to Min-soo Han at hms@hankyung.com