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…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.
The FDA announcement:
Today, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD) … The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools. There were no serious adverse events reported. The most common adverse events observed with EndeavorRx are: frustration, headache, dizziness, emotional reaction, and aggression.
The FDA reviewed the EndeavorRx through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
News in Context:
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- Pending FDA review and approval, research findings pave way for Akili’s EVO to become first brain training platform prescribed for ADHD
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