(image: Korea Bizwire)
SEOUL, Feb. 15 (Korea Bizwire) — South Korea’s drug safety ministry said Wednesday that it has granted the first-ever domestic marketing license for a digital treatment device, allowing the product to be sold in the country.
“We’ve decided to give approval to Somzz as a digital therapeutics device,” Minister of Food and Drug Safety Oh Yu-kyoung said in a press briefing.
Somzz, developed by homegrown health management solution provider Aimmed Co., is a mobile application to treat insomnia patients based on cognitive behavioral treatment.
It is the first time that the South Korean drug safety authority has approved a digital treatment device, a new type of software-based medical treatment program to prevent, manage or treat a medical disorder or disease.
Somzz helps people improve insomnia symptoms by increasing sleep efficiency through sleep habit training, real-time feedback, and behavioral intervention provided by the mobile app for six to nine weeks, according to the ministry.
The ministry said patients had shown statistical improvement in their insomnia symptoms before and after using Somzz in Aimmed’s six-month clinical tests held in three local institutions.
The ministry said it will broaden the way for local companies to develop quality digital therapeutics devices through providing more detailed review guidelines and help South Korea, one of the world’s IT powerhouses, lead the global standard in the booming sector.
(Yonhap)
