Rowan (co-CEOs Seung-Hyun Han and Sung-Min Kang) announced on the 25th that its digital therapeutic device “SuperBrain DEX” received product approval from the Ministry of Food and Drug Safety (MFDS) on the 24th.

SuperBrain DEX is a tablet-based cognitive training software. Once prescribed, patients can train their cognitive function at home—without visiting the hospital—seven days a week for a total of 16 weeks.

The solution features an intuitive user interface and an automated difficulty-adjustment algorithm, making it easy for older adults to use. The MFDS approval was based on the results of a randomized, evaluator-blinded (RCT) clinical trial conducted at 12 tertiary hospitals across Korea, involving 140 patients with mild cognitive impairment (MCI) aged 50 to 85.

According to the study results, scores on the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) showed a statistically significant improvement in the SuperBrain DEX group compared with the control group after 16 weeks. Furthermore, the fact that improvements in cognitive function translated into better performance in everyday functioning was highlighted as a key outcome of this trial.

The clinical investigators commented, “SuperBrain DEX not only improved cognitive function, but also demonstrated meaningful improvements in instrumental activities of daily living (K-IADL) and in the Clinical Dementia Rating–Sum of Boxes (CDR-SB), an indicator of dementia progression. This proves that it is more than a simple training app—it is a digital therapeutic device with real clinical efficacy.”

The biggest differentiator of SuperBrain DEX is that it extends the traditional hospital-centered treatment model into the home. Because older patients can continue treatment without repeated hospital visits, the solution is particularly useful for those with limited mobility or those living in regions with poor access to medical services.

Experts note that this approval is significant in several respects:

• It is one of the first large-scale clinical trials in Korea to demonstrate the efficacy of a digital therapeutic in patients with mild cognitive impairment.

• It helps establish an elderly-friendly, home-based treatment model.

• It may accelerate future reimbursement discussions and broader adoption in routine clinical practice.

Rowan is a company specializing in digital therapeutics for mild cognitive impairment and dementia. With its elderly-friendly UI/UX design, development grounded in large-scale clinical evidence, and a strategy focused on continuous improvement using real-world data, Rowan is emerging as a leader in Korea’s digital healthcare market.

A Rowan representative stated, “SuperBrain DEX is expected to establish itself as the first at-home cognitive function improvement solution that allows patients to receive consistent treatment from the comfort of their own homes.”