FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD

FDA

15 June 2020 - Today, the U.S. FDA permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder. 

The prescription-only game-based device, called EndeavorRx, is indicated for paediatric patients ages 8 to12 years old with primarily inattentive or combined-type attention deficit hyperactivity disorder (ADHD) who have demonstrated an attention issue. 

EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorisation by the FDA for any type of condition.

Read FDA press release

Michael Wonder

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Michael Wonder

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US , Regulation , Paediatrics , Software