FDA clears first videogame to be prescribed to kids with ADHD: EndeavorRx by Akili Interactive Labs

Screenshot of EndeavorRx 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. The FDA announcement: FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD Today, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit...
Source: SharpBrains - Category: Neuroscience Authors: Tags: Cognitive Neuroscience Health & Wellness Professional Development Technology 510(k) Adam Gazzaley adhd Akili Interactive Labs computerized testing De Novo digital therapeutics EndeavorRx FDA game-based therapeutic TOVA videog Source Type: blogs