Inside STAT: Will the FDA give the go-ahead to a prescription video game?

Inside STAT: Will the FDA give the go-ahead to a prescription video game?

AN IMAGE TAKEN FROM AN EARLY VERSION OF THE VIDEO GAME BEING DEVELOPED BY AKILI INTERACTIVE LABS. (AKILI)

It’s been a year and a half since Akili Interactive Labs asked the FDA to approve the health tech startup’s video game, one that physicians could prescribe to kids with ADHD. That green light has yet to come through, spurring questions about the delay. It’s unclear, for instance, whether the agency has asked Akili to make changes or run a new study — although the company’s CEO, Eddie Martucci, tells STAT that he believes Akili has studied its game rigorously, and that the data speak for themselves. Still, the delay could be a sign of the complexity of the FDA’s task at hand: There is no precedent for evaluating a medical product that’s played on a tablet and whose delivery system is much more ambitious and targeted than other digital products that have come before it. STAT’s Rebecca Robbins has more here.