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, and that the data speak for themselves.
Asked if he felt disappointed that the regulatory go-ahead hasn’t come sooner, Martucci conceded: “The process is obviously longer than some of us had hoped, I can say that much. And any disappointment is more that we’re not yet getting a product to ADHD families that they really need.” See more here.