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.
"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," Jeffrey Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in the news release. "The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics."
The FDA's decision follows consideration of data from multiple studies that used the Test of Variables of Attention, academic performance measures, and other assessment tools to measure improvement in attention function in more than 600 children.
The most frequently seen adverse events with the therapy were "frustration, headache, dizziness, emotional reaction, and aggression." No serious adverse events were reported, according to the agency.
The device was reviewed through the agency's De Novo premarket review pathway, used for "new type" devices with low to moderate risk. As a result of this action, there will be a new regulatory classification, and future devices of this type with the "same intended use" can receive marketing authorization via the FDA's 510(k) premarket notification process by showing that they are substantially equivalent to the predicate device, EndeavorRx.
ADHD is a chronic condition that usually starts in childhood. It affects approximately 4 million children aged 6 to 11 years. Symptoms include difficulty remaining focused and paying attention, poor impulse control, and hyperactivity.
The Centers for Disease Control and Prevention recommends that a trained healthcare professional conduct the ADHD evaluation and that the evaluation include assessment of inattention, hyperactivity, and impulsivity, and the extent to which these symptoms affect the child's development or ability to function.
Cite this: FDA Approves Video Game-Based Therapy for Kids With ADHD - Medscape - Jun 16, 2020.