In mid-2018, the startup Akili Interactive Labs asked the Food and Drug Administration to let it do something that’s never been done before: market a video game that physicians would prescribe to kids with ADHD.
A year and a half later, that green light has yet to materialize. It’s unclear whether that’s a sign of trouble — the company wouldn’t say whether the agency has asked it to make changes or run a new study — or simply a reflection of the complexity of evaluating a medical product without precedent.
Akili’s CEO, Eddie Martucci, told STAT the company is having ongoing discussions with regulators. He said Akili believes it has studied its game rigorously.
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Akili’s video game is played on a tablet. It sends players through landscapes like a molten lava river and an icy winter snowscape, rewarding them with stars and points as they finish tasks. Akili sees the video game as the delivery system for targeted algorithms that can activate certain neural networks in the brain.
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[ADHD specialist Sandra] Loo said she expects that if Akili’s game comes to market, it will be prescribed using a precision medicine approach to only those patients likely to benefit, rather than to all kids with ADHD.
