FDA approves first therapeutic video game
Here’s a new one: The FDA has just approved a prescription video game.
The brainchild of a couple of cognitive scientists who built the prototype technology over a decade ago, the video game is designed to help improve attention function in kids with ADHD. It was developed by Akili Interactive, one of two major health tech video game companies, and is called EndeavorRx.
Doctors can prescribe it for kids ages 8 to 12 with ADHD and a history of attention issues. A price has yet to be announced, but an Akili spokesperson said in an email that they are working to get coverage from insurers and to “expect pricing to be in the range of other treatments like drugs and behavioral therapy currently used in children with ADHD.”
The approval is the culmination of a years-long effort to convince regulators that a video game could even be a prescription therapy. Akili was founded in 2011, with technology licensed from Adam Gazzaley’s lab at the University of California, San Francisco, and got early backing from Pfizer, Shire and PureTech, among others. (Pear Therapeutics, the other major company in the space, was founded 2 years later.) The idea was that, with the right algorithms, a game could retrain neural networks and help people with certain cognitive disorders multitask, focus, and process information.
Even as they tested the software in Alzheimer’s, ADHD, depression and autism, they encountered skepticism about the potential impact. A 2013 meta-analysis analyzed 46 experiments on video games, and found they produced “negligible effects for executive function.” Akili first asked for FDA approval in mid-2018. For drugs, at least, a decision generally comes within 10 months.
EndeavorRx was finally approved based on 5 clinical trials, including a study published on April 1 in The Lancet Digital Health that found that 25 minutes of game play per day, 5 days a week, for 4 weeks “might be used to improve objectively measured in attention in pediatric patients with ADHD.” It was cleared under the FDA’s De Novo program for a new type of low- or moderate-risk device.
Although only approved today, the game has actually been available for over a month. In April, the FDA relaxed regulations for low-risk mental health devices, and Akili launched a site that allowed children to get the game for free for up to three months.
The game sends kids through landscapes teeming with lava or ice, or on underwater missions, and rewards them for completing various tasks.