![]() Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”ĪDHD is a common disorder that begins in childhood, affecting approximately 4 million children ages 6-11. “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, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. 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. EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition. ![]() The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). ![]()
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |