Rowan Digital Therapeutic 'Superbrain DEX' Designated as Innovative Medical Device

Designation of Innovative Medical Device No. 48

Rowan, a developer of digital therapeutic devices, announced on the 2nd that 'Superbrain DEX' has been designated as the 48th innovative medical device.

Rowan Superbrain DEX.
[Image provided by Rowan]

Superbrain DEX is a digital therapeutic device that provides customized training based on cognitive intervention therapy for patients with mild cognitive impairment experiencing memory decline. Artificial intelligence (AI) analyzes basic information such as individual cognitive function levels, age, gender, and education to present optimized cognitive training tailored to each person. The purpose is to improve cognitive function through this process.

Innovative medical devices are selected based on their significant improvement or expected improvement in safety and efficacy compared to existing medical devices or treatments. They are designated under the supervision of the Ministry of Food and Drug Safety, based on the 'Medical Device Industry Promotion and Innovative Medical Device Support Act.'

Products designated as innovative medical devices receive benefits such as special approval procedures (stepwise review and priority review) and preferential participation in government-supported projects. To date, the Ministry of Food and Drug Safety has designated a total of 49 products as innovative medical devices.

Seunghyun Han, CEO of Rowan, said, "Superbrain can help continuously improve the cognitive abilities of patients with mild cognitive impairment without constraints of time and space," and added, "Based on the encouraging achievement of being designated as an innovative medical device, we will devote all efforts to the confirmatory clinical trials of digital therapeutic devices scheduled to be conducted at 12 institutions."

Rowan was established in 2017 and is a company that develops digital therapeutic devices using big data and AI.