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FDA approves digital game for children with ADHD :

June 16, 2020

Some children with attention-deficit/hyperactivity disorder (ADHD) may soon get treatment through use of a video game.

The Food and Drug Administration (FDA) gave marketing approval to EndeavorRx, a game-based digital therapeutic device from Akili Interactive to help improve attention.

“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a news release.

FDA officials said it is the first game-based therapeutic the agency has ever approved. The device is intended for children ages 8-12 years old and requires a prescription. It is intended to be used along with other treatment modalities including therapy, medication and/or education programs.

The device was tested in more than 600 children across several studies including a randomized controlled trial detailed in The Lancet Digital Health. That study found improved attention with no serious adverse events. The most common adverse events were frustration, headache, dizziness, emotional reaction and aggression.

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