It's a big step into a future of video games for kids with ADHD and potentially other mental health disorders: the FDA has approved marketing the first video game as a medical device. (Or, in agency parlance, a "game-based therapeutic digital device.")
Akili Interactive's long written about and awaited game, EndeavorRX, was approved using the FDA's De Novo pathway, meant for low/moderate risk novel devices.
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According to the FDA's press release, the agency assayed data from multiple studies of over 600 children. The studies assessed whether the video game for kids with ADHD spurred "demonstrated improvements in attention function."
Most trumpeted? A prospective randomized control study published this past February in The Lancet.
While the study's own authors — who "may own stock options" in Akili, according to conflict of interest disclosures — aren't yet saying that video games for kids with ADHD could replace other therapies, it did improve objective measures of attention.
After four weeks of treatment, children who played the game showed an improvement in their Attention Performance Index (API) scores, compared to a control group that played a "placebo" video game that wasn't designed to improve attention.
When researchers looked at whether these changes in objective attention scores corresponded with subjective behavioral or cognitive improvements, the kids who played EndeavorRX did improve — but so did kids who played the "placebo" game, and the difference between the two wasn't statistically significant. (Mobile Health News has a more detailed breakdown of the study.)
Akili had already launched the game on a trial basis in April, taking advantage of the FDA's relaxed rules for mental health devices during the COVID-19 pandemic. But the video game for kids with ADHD can now be prescribed by doctors, and potentially covered by insurance.
Most exciting — and historic — may be EndeavorRx's role in creating an entirely new category of medical devices.
Most exciting — and historic — may be EndeavorRx's role in creating an entirely new category of devices. One can foresee a world in which video games for kids with ADHD are joined by games tailored to other psychiatric and neurological conditions.
"We're proud to make history today with FDA's decision", Eddie Martucci, CEO of Akili, said in a statement.
“With EndeavorRx, 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.”
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