FDA approves game marketed as a treatment for ADHD

Prescription-only device is first game-based therapy the US agency has approved for any condition

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.

EndeavorRX is an action game intended to address attention issues

EndeavorRX is an action game intended to address attention issues

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.

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