In June 2020, the FDA cleared the first-ever game-based digital therapeutic. The FDA cleared EndeavorRx, a prescription-only game from Akili Interactive, that is designed to improve attention and focus for children ages 8 to 12 who have been diagnosed with attention deficit hyperactivity disorder (ADHD). The FDA based the clearance on the agency’s own April 2020 COVID-19-related guidance on digital health devices for treating psychiatric disorders. The FDA issued the guidance to reduce patient and healthcare worker exposure.

Akili recently announced EndeavorRx enhancements to add new features and functionalities to the game. Akili is ramping up its marketing to introduce EndeavorRx to more patients and healthcare professionals. According to an Akili news release, the new video game enhancements do not change the regulated core of the technology of the game, but strengthen the gameplay experience,

The new features and functions focus on gameplay progress, more player choices, and greater personalization while patients play the games. For example, players can choose new creatures and costumes, take on new quests and missions, and create and build their own universes within the game. The enhancements result in longer player interest and engagement, according to the developer. Akili used player and caregiver feedback, gameplay data, and longitudinal research to guide the changes and choose the enhancements.

EndeavorRx may be the first gameplay-based digital therapeutic tool to benefit from the FDA’s pandemic-driven guidance. We suspect the success of the early products will have a direct influence on additional digital health treatments.