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.
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