FDA Approves Video Game-Based Therapy for Kids With ADHD
The US Food and Drug Administration (FDA) has allowed marketing of a "prescription-only game-based" digital therapeutic device for children aged 8 to 12 years who have primarily inattentive or combined-type attention-deficit/hyperactivity disorder (ADHD) and problems with inattention. The EndeavorRx device (Akili Interactive) is indicated for the improvement of attention function, as assessed by computer-based testing. It is the first device of its kind to be approved for this indication and is the first video game–based therapeutic device to receive marketing authorization from the FDA for any condition, according to an FDA news release. "The device is intended for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder," the FDA explains in a news release.
@panama 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. The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics