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EndeavorRx is a prescription-only game designed to help improve attention in 8- to 12-year-olds with ADHD who have confirmed attention problems.
It is the first game-based treatment authorized by the FDA for any condition.
The game from Akili Interactive is meant to be part of a treatment plan that may include health care provider-directed therapy, medication and/or education, according to the 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," Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said in an agency news release.
Approval of the device follows several studies that included a total of 600 children. The studies evaluated whether the game led to improvements in areas such as attention and school performance.
Dr. Andrew Adesman, chief of developmental and behavioral pediatrics at Cohen Children's Medical Center in New Hyde Park, N.Y., said the device seems promising and is likely to appeal to parents of kids with ADHD. But the jury is still out on its effectiveness, he added.
"Presently, many parents of children with ADHD have difficulty accessing appropriate counseling services and are reluctant to consider treatment with medications that have proven effectiveness," Adesman said. "To the extent that this product is only available by prescription, it is unclear to what extent insurance companies will cover the cost of this treatment approach."
He said the video game is likely to be most effective in conjunction with other treatments.
ADHD is a common disorder that begins in childhood and affects about 4 million 6- to 11-year-olds in the United States.
ADHD should be diagnosed by a professional based on symptoms such as inattention, hyperactivity and impulsivity that interfere with functioning or development, according to the U.S. Centers for Disease Control and Prevention.
-- Robert Preidt
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