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Gaming For Attention: FDA Grants De Novo For Novel ADHD Treatment

Akili Interactive’s EndeavorRx has opened the door for other digital therapies to get to market faster

A new video game pediatric ADHD treatment has opened the door for other such novel therapies to come to market using the less stringent 510(k) pathway, as interest in such products have gained significant steam over the past few years.

Endeavor Soup, video game being used to treat kids with ADHD.
EndeavorRx is the first game-based treatment for children with ADHD, paving the way for other game-based digital treatments under development • Source: Shutterstock/Akili Interactive

For the first time, the US Food and Drug Administration has granted de novo marketing authorization for a game-based digital treatment aimed at children with attention deficit hyperactivity disorder (ADHD). It’s not just the first gaming treatment for ADHD – it’s also the first game-based treatment for any condition to get the nod from the FDA, which opens the door for similar therapies.

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