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Gaming For Attention: FDA Grants De Novo For Novel ADHD Treatment

Akili Interactive’s EndeavorRx has opened the door for other digital therapies to get to market faster

Executive Summary

A new video game pediatric ADHD treatment has opened the door for other such novel therapies to come to market using the less stringent 510(k) pathway, as interest in such products have gained significant steam over the past few years.

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Kids, Time To Play Your Medicine: Akili Prepares Launch Of EndeavorRx Video Game For ADHD

After being first to receive FDA clearance for a prescription-only software to treat ADHD and raising total funding of $230m, Akili plans a US launch in 2022 while targeting other indications.

Kids, Time To Play Your Medicine: Akili Prepares Launch Of EndeavorRx Video Game For ADHD

After being first to receive FDA clearance for a prescription-only software to treat ADHD and raising total funding of $230m, Akili plans a US launch in 2022 while targeting other indications.

Akili Pays $37.5M To License Tali’s Tech For Early Childhood Attention Impairments

Tali’s video game assesses and improves attention in children three to eight years old. Akili markets the EndeavorRx prescription video game therapy to improve attention function in children ages eight to 12. The deal will help Tali commercialize its technology in the US.

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