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FDA approves marketing a videogame as medicine for the first time

It's for children with ADHD

In a historic first, the US Food And Drug Administration have approved the use of a videogame as medicine. It's for a specific, "prescription-only game-based device, called EndeavorRx", which is intended to help children with ADHD. Kids have to fly a sci-fi plane around alien environments, in theory helping them learn how to keep their attention focused.

The FDA say it's "the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition". The game is iOS-only, but it certainly sets an interesting industry precedent.

According to Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, "The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics." The FDA do also note that "the device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder". So it's definitely not a 'hand this game to your kids and you're done' type deal.

The FDA say they "reviewed data from multiple studies in more than 600 children", and found that EndeavorRX significantly improved attention according to various measures.

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As noted by Science Alert, "The most significant [study], involving 348 participants, showed that 36 percent of kids showed improvement in at least one objective measure of attention after playing EndeavorRx for five days a week for four weeks." For comparison, that's notably higher than the "21 percent of kids in the control group who showed similar improvements", who "were playing a word game that wasn't specifically designed to target ADHD". You can study the study for yourself here.

There's nothing ostensibly wrong with any of this, though as Science Alert also highlight, that study was conducted by bodies with a financial interest in finding positive results. In that study the game was also "only tested for a month on kids not taking medication for ADHD", so it's not clear if the effects are noticeable if they are.

This article has been edited to remove comments I made about the pharmaceutical industry's impact on ADHD diagnosis. They were misjudged, and this wasn't the place to talk about it. Sorry.

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