NewNaps Visual Impairment Treatment Software 'Vivid Brain' Designated as Innovative Medical Device

The Ministry of Food and Drug Safety announced on the 22nd that it has designated NewNaps' visual impairment treatment cognitive therapy software, 'VIVID Brain,' as the 33rd innovative medical device.

Newnaps' visual impairment treatment cognitive software 'Vivid Brain'
[Photo by Ministry of Food and Drug Safety]

VIVID Brain is the first domestic product designed to improve visual impairment caused by brain damage. It is cognitive therapy software that helps improve visual impairment by providing virtual reality-based visual perception learning training to patients with visual impairment, who experience blind spots in part or all of their visual field due to damage to the brain's visual center.

VIVID Brain enhances the brain's perceptual ability through repetitive visual stimulation training, thereby changing brain function. It offers visual perception learning training with user-customized visual stimulus locations and difficulty levels via virtual reality devices, improving visual impairment through enhanced brain plasticity. The Ministry of Food and Drug Safety stated, "New mechanisms of action and intended uses have been applied," and added, "The technology's innovativeness and distinctiveness were recognized, leading to its designation as an innovative medical device."

Instead of complementary compensation or substitution methods traditionally used to treat visual impairment caused by brain damage, VIVID Brain implements a fundamental solution by enhancing brain plasticity through visual perception learning training, with clinical effects confirmed in prior studies. Currently, confirmatory clinical trials are underway, and it is expected to aid in the treatment of patients with visual impairment caused by brain damage in the future.

With the designation of VIVID Brain as an innovative medical device, a total of 33 products have now been designated as innovative medical devices. Among these, six products were designated through the integrated review system for innovative medical devices conducted jointly by the Ministry of Food and Drug Safety and related ministries and agencies.