510(k)

In a land­mark deci­sion, FDA green­lights a video game for kids with ADHD (STAT):

The Food and Drug Admin­is­tra­tion on Mon­day for the first time gave a green light to a game-based ther­a­peu­tic: a video game meant to be pre­scribed to kids with ADHD.

The game, known as Endeav­or­Rx and devel­oped by Boston-based Akili Inter­ac­tive Labs, can now be mar­ket­ed as a way to improve atten­tion func­tion in kids with ADHD as mea­sured by com­put­er­ized test­ing. Physi­cians can pre­scribe it to chil­dren between the ages of 8 and 12 who have an ADHD diag­no­sis and have demon­strat­ed an issue with attention.

The FDA’s move is a land­mark deci­sion in the emerg­ing dig­i­tal ther­a­peu­tics sec­tor: In addi­tion to being the first game to be mar­ket­ed as a ther­a­py for any type of con­di­tion, Endeav­or­Rx is the first dig­i­tal ther­a­peu­tic meant to improve symp­toms asso­ci­at­ed with ADHD, the FDA’s announce­ment said…The game was born in the Uni­ver­si­ty of Cal­i­for­nia, San Fran­cis­co lab of neu­ro­sci­en­tist Adam Gaz­za­ley, and was licensed out by Akili, which pol­ished and test­ed the game in clin­i­cal tri­als. Akili spent the past two years wait­ing on a reg­u­la­to­ry deci­sion from the FDA.

[Read more…] about FDA clears first videogame to be pre­scribed to kids with ADHD: Endeav­or­Rx by Akili Inter­ac­tive Labs