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FDA Permits Marketing of Digital Game to Improve Attention in ADHD Children (2020)
FDA permits marketing of the first game-based digital therapeutic device, EndeavorRx, for children with ADHD.
The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.” The most common adverse events observed with EndeavorRx are: frustration, headache, dizziness, emotional reaction, and aggression.
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