The FDA has cleared its first video game for children with attention deficit hyperactivity disorder (ADHD), allowing Akili Interactive’s EndeavorRx to be prescribed as a digital therapeutic.
Played on a touchscreen, the software provides challenges and stimuli that target the brain’s neural systems linked to focus, cognitive function and multitasking. It is designed to be used as part of a wider therapy regimen, which may also include medication or educational programs, to help improve attention in children 8 to 12 years old.
“With EndeavorRx, 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. “With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues.”
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To receive a federal green light, the agency reviewed data from five clinical studies spanning more than 600 children, demonstrating improvements in attention as well as academic performance and other assessments.
In one study, published in The Lancet Digital Health Journal earlier this year, children showed objective improvements after playing the game for just one month. After two months of treatment, about two-thirds of parents reported meaningful changes in day-to-day impairments. The FDA granted Akili, a former Fierce 15 winner, a de novo clearance, describing the game as the first of its type.
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“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,” said Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
In addition, Akili plans to pair the prescription software with a wider care program that includes a mobile tracking app and personal support services for caregivers.
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“The clearance of EndeavorRx marks the culmination of nearly a decade of research and development and was fueled by the commitment of our team and collaborators to challenge the status quo of medicine,” said Akili’s senior vice president of medical devices, Scott Kellogg. “This would not have been possible without the dedication of our clinical research partners and hundreds of families who gave their time and energy to participate in our clinical trials.”