FDA permits marketing of device to improve attention function in kids with ADHD

The US Food and Drug Administration (FDA) permitted marketing of Akili Interactive’s EndeavorRx, the first game-based digital therapeutic device meant to improve attention function in children who have attention-deficit/hyperactivity disorder (ADHD).¹ The prescription-only device is indicated for children aged 8 to 12 years with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. The FDA reviewed the device via the De Novo premarket review pathway.

EndeavorRx is meant to improve attention function, measured by computer-based testing. It is meant to be used as one element of a therapeutic program that could also include educational programs, medication, or clinician-directed therapy. In the review of the device, the FDA examined data from a number of studies that covered over 600 children. The studies looked at demonstrated improvement in attention function, academic performance measures, and other assessments. There were no serious adverse events reported in the studies and the most common ones reported were frustration, headache, dizziness, emotional reaction, and aggression.

In the press release for the marketing approval, Jeffrey Shuren, MD., JD., director of the FDA’s Center for Devices and Radiological Health stated why the approval was important saying, “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.”

Reference:

1. US Food and Drug Administration. FDA permits marketing of first game-based digital therapeutic to improve attention function in children with ADHD. US Food and Drug Administration. Published June 15, 2020. Accessed June 16, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd