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 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.