It's the first time the FDA has cleared a digital therapy for improving ADHD symptoms, and the first time the agency has ever authorized marketing of a game-based therapy for any condition.
The FDA says it looked at data from multiple studies in more than 600 children. A video of the game shows a character traveling a race course-like path in a hover board. Sensory and motor tasks are designed to help the player improve cognitive functioning.
"We're proud to make history today with FDA's decision," Akili CEO Eddie Martucci said in a statement. "We're using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment."