Imocog announced on the 3rd that its digital therapeutic device (DTx) 'Cogthera' for improving cognitive function in patients with mild cognitive impairment (MCI) has obtained the Medical Device Regulation (MDR) certification for European Conformity (CE).
CE MDR is an international regulation that must be strictly followed to export products to Europe. With this certification, Imocog can now sell Cogthera in the European Union (EU) and countries based on CE certification.
Imocog is developing dementia solutions covering the entire cycle from prevention to diagnosis and treatment. Among them, Cogthera, a DTx for patients with mild cognitive impairment, received approval for a confirmatory clinical trial plan from the Ministry of Food and Drug Safety last year and is currently conducting clinical trials. To expand Cogthera globally, Imocog established its German branch 'Cogthera GmbH' in 2022 and has been developing global solutions supporting languages such as German and English.
Leveraging this CE MDR certification, Imocog plans to conduct large-scale clinical trials in Germany to enter the German DTx reimbursement system (DiGA). DiGA is regarded as the most advanced reimbursement system in the DTx field, and Imocog aims to be the first domestic company to enter DiGA.
Lee Jun-young, CEO of Imocog, said, “We have used the German branch as a forward base for European expansion, accumulating extensive know-how for local medical device approval and reimbursement system entry,” adding, “We will accelerate local clinical trials and market entry based on this certification.”
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