FDA approved the marketing of EndeavorRx, a game-based digital therapeutic device for children with ADHD, marking the first of its kind. The device is for pediatric patients aged 8-12 with inattentive or combined-type ADHD. It aims to improve attention function using computer-based testing and is the first game-based therapeutic for any condition authorized by the FDA. EndeavorRx is to be used alongside therapy, medication, or educational programs. The FDA approval comes after reviewing data from multiple studies involving over 600 children. Common adverse effects include frustration and headache. EndeavorRx was granted marketing authorization to Akili Interactive.
https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd