FDA clears video game therapy for ADHD
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The FDA has granted marketing authorization for the first time for a video game that can improve the attention span in children with ADHD.
EndeavorRx (Akili Interactive) is a prescription-only, game-based device indicated for patients aged 8 to 12 years with primarily inattentive or combined-type ADHD who demonstrate attentive issues, the FDA said in a press release.
The device is intended to improve attention function through computer-based testing, the agency said. It is part of a therapeutic program that may include clinician-directed therapy, medication and/or educational programs that address ADHD symptoms.
“The EndeavorRX device offers a nondrug 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, MD, JD, who heads the FDA’s Center for Devices and Radiological Health, said in a statement. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
ADHD affects approximately 4 million children aged between 6 and 11 years, according to the FDA.
The agency reviewed data from multiple studies that included more than 600 children. There were no serious adverse events reports. Common events observed with EndeavorRX were frustration, headache, dizziness, emotional reaction and aggression.
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