App for fighting insomnia gets Innovative Medical Device status in South Korea

‘Sleep Thera’ was developed in partnership with Seoul National University Hospital’s Department of Neurology

Rowan Dunne

Published

22 hours ago

South Korea’s Ministry of Food and Drug Safety (MFDS) has praised local sleep tech creator Bell Therapeutics for its insomnia treatment smartphone app.

Two sources in the country reported Monday that Bell’s “Smart Thera” mobile application now has innovative medical device status in the ministry’s advanced technology category.

It is a stand-alone medical gadget composed solely of software, without any hardware components, as described by the company. Many digital health apps can be classified as devices if they are deemed efficacious enough.

This prescription digital therapeutic works by using advanced algorithms to assess biometric signals and generate customized auditory and visual stimuli for the user. It is intended to reduce hyperarousal — a common cause of insomnia characterized by states of heightened physiological and psychological stress, general irritability and elevated heart rate.

PTSD, anxiety disorder, depression and bipolar disorder are known to cause hyperarousal, thereby contributing to increased rates of insomnia among those with the mental health conditions.

Sleep Thera harnesses proprietary “Sonified Neuromodulation” platform technology to improve the user’s sleep quality and duration.

Sleep Thera earns other valuable certifications

The news follows the app receiving medical device certification in the European Union at the end of February. Also, a Good Manufacturing Practice stamp from MFDS in August.

Bell Therapeutics was founded in 2023 in Seoul and has established a subsidiary in the United States. There, the company has initiated research partnerships with Boston University, the University of Iowa and UC San Diego’s Department of Physiology.

“We have positioned our U.S. subsidiary as a forward base for global expansion, establishing strategies for local medical device approvals and reimbursement system entry,” CEO Jae-Eun Lee said earlier this year.

In 2024, he attended a startup investor event in Seoul hosted by the American tech company 42Geeks.

“We coordinate invite only tech tours around the world,” 42Geeks says.