In a landmark decision, FDA greenlights a video game for kids with ADHD

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.

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The game sends players through landscapes like a molten lava river and an icy winter wonderland, rewarding them with stars and points as they finish tasks. Akili sees the video game as a delivery system for targeted algorithms that can activate and strengthen certain neural networks in the brain. It’s more ambitious than the many digital health apps and software programs that aim to help patients manage medical conditions with education, tips, and reminders — and it’s long been seen as a crucial test case for the potential of the sector.

The FDA’s announcement said the game is meant to be prescribed as part of a broader therapeutic program that might also include therapy and medication.

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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.

Despite just getting clearance from the FDA on Monday, the game has been available for the past few months under an unusual early rollout prompted by the pandemic. Following the FDA’s move in April to relax regulations on low-risk mental health devices during the pandemic, Akili set up a website to make its game available for free for eligible children.

Now, however, the company will have leverage to try to get physicians to prescribe the game and insurers to pay for it.