South Korean medical technology startup Ybrain said Monday that its depression-targeting headband wearable, Mindd, has obtained quality certification and marketing approval in Europe.

Developed exclusively by Ybrain, Mindd is a headband that sends weak electric currents to the frontal lobe, stimulating the region of the brain whose decreased activity is associated with depression. 

As a portable device, it allows patients to treat depression outside the hospital, including at home and other places.  

The device was approved by Korea’s Ministry of Food and Drug Safety in March this year, as a medical wearable for treating depression. It is already in use at 12 major hospitals in Korea. 

And now, Mindd has newly secured the ISO 13485 and CE MDD marketing approvals needed to enter the European market.

The former certifies that a company’s medical device quality management system is up to par with international standards, while the latter ensures that a product meets the essential requirements of all relevant European Medical Device Directives. The CE mark is a legal requirement for selling a medical device in EU markets.

“Starting with the new ISO 13485 and CE MDD approvals in Europe, we will work together with more global partners to actively target the European market,” said Ybrain’s founding CEO Lee Ki-won.

Established in 2013, Ybrain was co-founded by three engineers from the Korea Advanced Institute of Science and Technology -- including Lee, a former researcher at Samsung Electro-Mechanics -- with the aim to develop wearable devices to treat mental disorders including depression and Alzheimer’s disease.

By Sohn Ji-young (jys@heraldcorp.com)