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Some concussion tests could give wrong results, FDA warns :

April 11, 2019

The Food and Drug Administration (FDA) is warning parents, coaches and health care providers not to use products that claim to assess, diagnose or manage a head injury, including concussion. Several products, such as smartphone apps marketed for use during sporting events, are not FDA-approved. Using these unapproved medical devices could lead to an incorrect diagnosis, according to the FDA.

A diagnosis of head injury can only be made after a child is examined by a health care professional, according to the American Academy of Pediatrics (AAP).

During the exam, the health care provider might use one of a handful of medical devices that is FDA-approved as part of the process of diagnosing, treating and managing head injury. According to the AAP, there is no test to predict how long it will take for a child to recover.

If a child is suspected of having a head injury, medical attention should be sought right away.

Report problems from devices to the FDA at http://1.usa.gov/1MTK1cU. For more about pediatric head injuries, visit www.healthychildren.org.

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