FDA clearance will enable Akili to forge deeper into the massive ADHD management market in the US
— which is yet to be FDA cleared — will have to expand their features in order to appeal to parents who will have already become accustomed to using Akili's platforms for their ADHD-diagnosed children.
The FDA has taken a more digital health-friendly stance amid the pandemic — and we think it'll continue knocking down regulatory hurdles for digital mental health platforms even after outbreaks subside. The FDA's approval of Akili's platform isn't surprising, given that it has back other telepsychiatry restrictions during the pandemic: It removed the requirement of digital mental health developers to submit a 510 premarket notification in early April — ensuring that telehealth tools land in consumers' hands more quickly. were able to release temporary versions of their platforms to treat ADHD and schizophrenia, respectively.
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