Rowan, a digital therapeutic device company (co-CEOs Seung-Hyun Han and Sung-Min Kang), announced on the 2nd that its product ‘SuperBrain DEX’ has been designated as the 48th Innovative Medical Device by the Ministry of Food and Drug Safety (MFDS).

SuperBrain DEX is a digital therapeutic device designed to provide cognitive intervention-based personalized training for patients with mild cognitive impairment (MCI) who experience memory decline. The device uses artificial intelligence to analyze a patient’s cognitive function, age, gender, and educational background to offer customized cognitive training, aiming to improve cognitive abilities.

Innovative medical devices are products that are expected to significantly enhance safety and effectiveness compared to existing medical devices or treatments. They are regulated under the ‘Medical Device Industry Promotion and Innovative Medical Device Support Act,’ with oversight from MFDS.

Products designated as innovative medical devices are eligible for regulatory exemptions (such as phased reviews and priority assessments) and preferential participation in government support programs. To date, MFDS has designated 49 products as innovative medical devices. The agency expects this system to contribute to the government’s national policy of transforming Korea into a global leader in bio and digital health.

Seung-Hyun Han, CEO of Rowan, commented, “SuperBrain has the advantage of continuously improving the cognitive abilities of MCI patients, regardless of time and location. We will fully dedicate our efforts to the confirmatory clinical trials of digital therapeutic devices, set to take place at 12 institutions, leveraging the positive results from being designated as an innovative medical device.”

Founded in 2017, Rowan is a company that develops digital therapeutic devices using big data and artificial intelligence. Its differentiated technology, combining AI with professional medical knowledge, provides personalized solutions. Rowan collects and analyzes cognitive function data to lead the future of non-drug therapies through IT innovation.