Recently, the USFDA has approved a video game to improve attention function in children with attention deficit hyperactivity disorder (ADHD). It is the first digital therapy for improving symptoms associated with ADHD, and the first game-based therapy that received marketing authorization by the FDA. This video game is indicated to improve attention function, and the outcome is measured by computer-based testing. It is indicated for pediatric patients aged 8 to 12 years and presenting with an attention issue with primarily inattentive or combined-type ADHD.
The device is intended as a therapeutic program component that may include clinician-directed therapy, medication, and educational programs. The FDA reviewed the video game through a regulatory pathway for low-to moderate-risk devices (de novo premarket review pathway) of a new type. This created a new regulatory classification…
