FDA keurt game goed die op de markt wordt gebracht als behandeling voor ADHDjuni 17, 2020
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The US Food and Drug Administration has given Akili Interactive approval to market its new video game as a treatment for attention-deficit/hyperactivity disorder (ADHD).
The agency announced the move yesterday, noting it is the first game-based therapeutic given that approval for any condition.
The game is called EndeavorRx and is a prescription-only treatment for children between the ages of 8 and 12 with primarily inattentive or combined-type ADHD and attention issues. The FDA said it has been shown to improve attention “as measured by computer-based testing.”
Akili suggests children play EndeavorRx 30 minutes a day, five days a week for a month. That treatment cycle can also be repeated, with the company saying cycles may produce more benefits with a break of up to four weeks in between.
Clinical trials also showed 9.3% of children reported adverse affects from treatment, including frustration (6.1%) and headache (1.3%). Dizziness, emotional reactions, nausea, and aggression were also reported, but not as frequently.
The approval was granted through the FDA’s De Novo program, which provides a path to approval for new medical devices with low to moderate risks.