FDA Agrees, Video Games are Good for Children
[Thursday, June 18, 2020]

​In a first of its kind, this week FDA approved a video game as a medical device for the treatment of children with ADHD. Besides the happy children who have one more reason to play more video games (as if they needed one), this presents a new opportunity for game developers. With this decision, FDA created a new class of medical devices, those based on video games to treat a variety of disorders and conditions. All the future developers would need to do is show substantial equivalence to the first device. Excessive video gaming is generally regarded as detrimental to mental health with the key word being “excessive”. Video games challenge different parts of the brain than conventional games by offering different physical and mental challenges. EndevourRx is an action game installed on a mobile device (the current version only supports iOS devices), available only by prescription, that involves steering, tapping, and combination of the two actions. The children are expected to play at least 30 minutes each day for at least 30 days, which additional 30 day “treatments” prescribed as needed by the treating physician. The FDA approval was based on clinical trials in about 600 children, with the pivotal data coming from a 348-subject randomized double-blind study in children 8-12 of age. In the blinded study, the control was a word finding game on a grid of letters. Not surprisingly, the children liked and responded to the action game better than the word building game. The testing process used by the developers, Akili Interactive Labs, shows the path to all the other developers with similar ambitions. Akili has several similar programs in the works for game-based treatment of autism, major depressive disorder, MS, traumatic brain injury, and others. The path to other such games as prescription devices will likely be more competitive. The most important issue for Akili is and will be the commercial success of their games. The action game developed by Akili looks very similar to many other action games. It should be relatively simple for someone to copy and improvise the design of the game. The general proof of concept that action games can improve cognitive skills, can be used by others, and will be. Akili is betting on being the biggest brand for prescription games but there are several other well-established developers in this space that will likely explore the regulatory pathway. In the end, the true winners might be children who may have a fun way to manage a debilitating disorder without drugs.