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SAN FRANCISCO — 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.

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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, and that the data speak for themselves.

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