The U.S. Food and Drug Administration on Monday approved a nondrug treatment for kids with attention deficit hyperactivity disorder.
It’s a video game.
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"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, director of the FDA's Center for Devices and Radiological Health, said in a press release. "The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics."
The game-based device is available only with a prescription and is designed for patients ages 8-12 with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.
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EndeavorRx is the first game-based therapy approved by the FDA for any type of condition. It is designed to improve attention function, as measured by computer-based testing, and the first to improve symptoms associated with ADHD.
ADHD affects about 4 million children ages 6-11. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity.
The FDA reviewed data from multiple studies in more than 600 children to see if there were improvements from the device. There were no serious adverse reactions reported, but some kids experienced frustration, headaches, dizziness, emotional reactions and aggression.
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