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FDA Approves First Game-Based Therapy for ADHD

  • June 24, 2020
  • ADHD, Patients and Families

The Food and Drug Administration (FDA) this month approved a video game-based therapy for treatment of attention-deficit/hyperactivity disorder (ADHD). This is the first game-based therapy, called a digital therapeutic device, approved by FDA for any type of condition.

The game, called EndeavorRx, was developed Akili Interactive Labs and delivers treatment through an engaging action video game experience. It will be available only by prescription and is intended to improve attention function in children ages 8 to 12 with primarily inattentive or combined-type ADHD.

ADHD is one of the most common mental disorders affecting children and it also affects many adults. Symptoms include inattention (not being able to keep focus), hyperactivity (excess movement that is not fitting to the setting) and impulsivity (hasty acts that occur in the moment without thought).

ADHD affects an estimated 8.4 percent of children and 2.5 percent of adults. It is more common among boys than girls. Many ADHD symptoms, such as difficulty remaining still for long periods and limited attention spans, are common to young children in general. The difference in children with ADHD is that their hyperactivity and inattention are noticeably greater than expected for their age and cause distress and/or problems at home, at school or with friends.

The EndeavorRx program is designed for use as part of comprehensive treatment plan directed by a clinician, that may include medication and/or educational programs. The game-based therapy runs in one-month treatment cycles and takes about 25 to 30 minutes a day.

“We’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment,” Akili CEO Eddie Martucci said in a statement.

EndeavorRx uses technology designed to target specific neural systems in the brain. It simultaneously presents sensory stimuli and motor challenges designed to target and activate the neural systems involved in attention function. It uses adaptive algorithms to personalize the experience for each user. It challenges the individual and allows for continual monitoring of progress, according to Akili.

“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,” Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health said in a statement.


  • FDA News Release:  FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD. June 15, 2020
  • Akili Statement, “Akili Announces FDA Clearance of EndeavorRx™ for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game.” June 15, 2020.

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