Emocog, a South Korean digital healthcare startup, has achieved the ‘CE MDR’ marking for its cognitive therapy software, Cogthera.
The CE MDR (Medical Device Regulation) is an updated standard based on the Medical Device Directive (MDD) introduced by CE (Conformite Europeenne) in 1993, which underwent legislative revisions in 2017 to elevate quality and safety criteria. Compliance with this international regulation is essential for exporting products to the European market. As a result, Emocog is now authorized to market Cogthera in countries governed by the European Union and CE certification.
Emocog is developing a comprehensive dementia solution covering prevention, diagnosis, and treatment across the entire spectrum of dementia. Recognized for its differentiated technological capabilities and strong market potential, the startup secured seed investments shortly after its establishment from notable entities such as Naver D2SF, StoneBridge Ventures, SV Investment, GC Holdings, and Kakao. In 2022, Emocog became the first among domestic digital therapeutic solutions for mild cognitive impairment to receive approval for a confirmed clinical trial plan from the Ministry of Food and Drug Safety.
Emocog’s ‘Cogthera,’ now with the acquired CE mark in Europe, is a digital therapeutic device designed to treat mild cognitive impairment. It digitizes collaborative research outcomes from dementia specialists spanning multiple years, enabling personalized treatments for patients in the comfort of their homes, overcoming constraints of time and space. Emocog has incorporated a voice-based solution for the convenience of the senior population.
Since 2022, Emocog has been establishing a presence in Germany for the global expansion of Cogthera, developing solutions that support languages such as German and English. Particularly, the recent attainment of the CE mark is an achievement that acknowledges Emocog’s independent Korean technological prowess in the global market, following the refinement of the global version through its German branch, Cogthera GmbH.
In the future, Emocog plans to conduct large-scale local clinical trials in Germany for inclusion in the DiGA (Digital Health Applications) system. If included in DiGA, patients will be able to use Cogthera with applied insurance coverage. This marks a first for a Korean company.
Lee Jun-young, the CEO of Emocog, expressed confidence in the company’s prospects in a statement released on Jan. 3, stating, “By establishing our German branch as a forward base for European expansion, we have accumulated a wealth of expertise in local medical device approval and entry into reimbursement systems.” He added, “With this certification as a foundation, we will expedite our local clinical trials and market entry.”
Currently, Emocog is actively seeking Series B investment to expand its presence not only in Europe but also in markets such as the United States and Asia.
