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Boston-based Akili Interactive Labs has secured the first-ever FDA approval to market a prescription video game and, in the process, created a new class of treatment delivered in pixels instead of pills.
Federal regulators on Monday cleared Akili's debut game, "EndeavorRx," to treat ADHD in children between 8 and 12 years old. The game features racing scenes that may recall Mario Kart, for some parents, but EndeavorRx isn't all fun.
"No question it is a good experience, but it's designed to be very difficult and repetitive — it has to be, to have the effect we need on the brain," said Akili Chief Executive Eddie Martucci. "We set expectations: There will be ebbs and flows, in terms of frustration or children being able to engage in it. It gets pretty tough."
The goal is to stimulate brain activity that gradually strengthens a child's attention and focus. Martucci said a typical, initial prescription will call for 30 minutes of gameplay, five days per week, for one month. Parents and doctors can then reassess and consider renewal.
In a series of clinical trials, Akili reported that roughly half of children showed improved attention after a month, according to their parents. About two-thirds made gains after two months.
Akili aims to make EndeavorRx available for download on Apple devices within a few months, said Martucci, who declined to disclose the game's price. He said it is unlikely that insurers will cover EndeavorRx, at first, "but we're very committed to working with the insurance industry and making sure that patients can get this covered."
That insurance coverage may be possible is a testament to the increasing acceptance of video games in mainstream culture. In the 1990s, video games were the scornful subjects of congressional hearings and were widely blamed for contributing to the Columbine school shooting.
Public attitudes about video games haven't completely reversed since then. Just last year, President Trump suggested a link between violent games and several mass shootings. But a body of research casts doubt on the existence of such a connection, and video games have gained a legitimacy that might once have seemed unthinkable.
"This FDA approval is a major milestone in the work of games and the recognition of it," said Casper Harteveld, who chairs Northeastern University's graduate program in game science and design. "I hope to see more of it."
Other video game makers could follow Akili, which spent nine years developing EndeavorRx and raised more than $140 million of venture capital, according to Crunchbase. The FDA has created a new regulatory classification for "digital therapies," making it easier for future games to earn the agency's approval.
Jeffrey Shuren, who directs the FDA's Center for Devices and Radiological Health, called Akili's game "an important example of the growing field of digital therapy and digital therapeutics." He added that "the FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics."
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