FDA Approves First Video Game-Based Therapy for Kids With AD
The USFDA has allowed marketing of a "prescription-only game-based" digital therapeutic device for children aged 8 to 12 years who have primarily inattentive or combined-type attention-deficit/hyperactivity disorder (ADHD) and problems with inattention.

-- The EndeavorRx device (Akili Interactive) is indicated for the improvement of attention function, as assessed by computer-based testing.
-- It is the first device of its kind to be approved for this indication and is the first video game–based therapeutic device to receive marketing authorization from the FDA for any condition.
-- The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder, explains FDA.
-- The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics.

The FDA's decision follows consideration of data from multiple studies that used the Test of Variables of Attention, academic performance measures, and other assessment tools to measure improvement in attention function in more than 600 children.

The most frequently seen adverse events with the therapy were "frustration, headache, dizziness, emotional reaction, and aggression." No serious adverse events were reported, according to the agency.

Source: https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd
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