Regulatory Focus™ > News Articles > Will CDRH Soon be Reviewing Video Games?

Will CDRH Soon be Reviewing Video Games?

Posted 07 August 2012 | By

Video games aren't traditionally known as medical devices. In fact, there aren't yet any approved by the US Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH), the US's medical device regulatory body. But all that could soon be changing.

At least one company, Boston and San Francisco-based Akili Interactive Labs, is on the verge of taking a video game it has specifically tailored for the treatment of attention deficit/hyperactivity disorder (ADHD) before FDA for potential approval.

Akili's game, named "Project: Evolution," would work on the presumption of prior research that action-oriented video games can improve a person's concentration. The advantage for the game would be the almost-total mitigation of side effects, likely giving it a highly positive risk-benefit assessment even if it doesn't prove as effective as first-line treatment for ADHD.

"We would aim to have efficacy and tolerability that outstrips any of the drugs," said Eddie Martucci, co-founder of Akili, to The Wall Street Journal.

The Journal notes Akili-and other companies-are likely to experience a difficult time obtaining approval from FDA due to the lack of established precedent for evaluating the devices. In the case of Akili, should it become the first device to go before CDRH, the agency will have to either adapt an existing regulatory framework to accommodate the device or establish an entirely new one.

The Future of Gaming as a Medical Device?

The potential for video games to act as medical devices is likely to increase in coming years as technological limitations continue to fall and once-impossible inventions become just another innovation using existing technologies. Consider the futuristic-looking virtual reality headset Oculus Rift. The device's developers promise an "immersive" experience, and the device has received effusive praise from some of the gaming industry's most prominent developers.

Even setting aside the particular device-it is, after all, still in development-similar virtual reality devices in the future could afford medical device manufacturers the ability to move far beyond the limitations of a two-dimensional screen and into an engrossing reality capable of mimicking real experiences.

It's not beyond the realm of possibility to imagine an engineered experience to ease social anxiety or help veterans of war recover from traumatic experiences, for example.

For now, though, game companies will have to start small. The four-person development team at Akili, backed by life sciences venture group Pure Tech Ventures, still needs to finish development of its game and undergo usability testing before it's fit to go before FDA reviewers to get its own score.


Read more:

WSJ - Games to Sharpen the Brain

Xconomy - Akili Interactive Seeks to Make Video Games That Heal, Not Harm

The Boston Globe - Boston-based Akili Interactive Labs developing therapeutic video games to enhance your cognitive functions


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