Akili Announces FDA Clearance of EndeavorRx™ for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game – Akili Interactive

Sourced from Akili Interactive

BOSTON, Mass – June 15, 2020 – Akili today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for EndeavorRxTM (AKL-T01) as a prescription treatment for children with attention-deficit/hyperactivity disorder (ADHD). Delivered through a captivating video game experience, EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. See full indication below. Persistent attention issues have a significant impact on the daily lives of millions of people. Attention impairments are a key component of ADHD for many children yet are often overshadowed by more overt symptoms of ADHD.

EndeavorRx was reviewed through FDA’s de novo pathway and its clearance creates a new class of digital therapeutics. EndeavorRx is designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning.

Read more here.

By Jessica Yap-Chung
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