Akili Interactive announced today that it received CE Mark approval for its EndeavorRx video game for children with attention deficit hyperactivity disorder (ADHD).
Boston-based Akili’s prescription treatment is delivered through a video game experience as a way to improve attention function as measured by computer-based testing in children between ages 8 and 12 with primarily inattentive or combined-type ADHD.
Despite garnering CE Mark approval, EndeavorRx is not yet available in Europe. However, the company intends to market the system in European Economic Area member countries while its near-term focus remains on its U.S. launch.
Last week, Akili received FDA clearance through the agency’s de novo pathway as a treatment designed to directly target and activate neural systems through the presentation of sensory stimuli and motor challenges to improve cognitive functioning. The company touts it as the first FDA-cleared prescription treatment delivered through a video game.
“Following our recent FDA clearance, the CE Mark is another important milestone for Akili,” Akili chief medical officer Dr. Anil Jina said in a news release. “This approval provides a path for the future expansion into Europe and will allow us to offer a new non-drug treatment option to families of children living with ADHD.”
Akili cited data from five clinical studies of more than 600 ADHD-diagnosed children supporting the use of EndeavorRx. One prospective, randomized, controlled study published in The Lancet Digital Health Journal revealed that EndeavorRx improved objective measures of attention in children with ADHD.
After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention. About half the parents of children involved saw a clinically meaningful change in day-to-day impairments after one month and that number bumped up to 68% after the second month of treatment.