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FDA: Don't Use Mobile Apps to Diagnose Concussions

15 May, 2019

By: Michael Popke

There is NOT an app for that; it just looks like there is.

In early April, the U.S. Food and Drug Administration issued a warning not to use medical devices marketed to consumers that claim to help assess, diagnose or manage concussions or traumatic brain injuries. The organization reminded parents, coaches and others that such tools — including smartphone apps marketed for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis. That, in turn, could potentially result in someone with a serious head injury returning to normal activities instead of receiving medical care.

The FDA provides a list of the limited number of medical devices it has cleared or approved to aid in the diagnosis, treatment or management of concussion, and all of them require an evaluation by a health care professional.

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement. “Products being marketed for the assessment, diagnosis or management of a head injury, including concussion, that have not been approved or cleared by the FDA are in violation of the law. … The FDA has alerted companies to our concerns and asked them to remove such claims. We will continue to monitor the marketplace for devices making these unsubstantiated claims and are prepared to take further action if necessary.”

In other concussion-related news:

  • A recent study of 43 former NFL players — designed to measure clinical depression and such somatic symptoms as pain, dizziness and shortness of breath — found no connection between concussion history and depressive symptoms among those men without physical symptoms. As detailed in the Journal of Neuropsychiatry and Clinical Neurosciences and explained by psychology and neuroscience news website PsyPost.org, former players with more concussions than others tended to report more somatic symptoms, which in turn was associated with depression. “We hope the average person takes away that the discussion of whether participation in contact sports can lead to later-life mental health and neurocognitive problems is complex, with many more questions than answers,” study authors Scott L. Zuckerman, co-director for research at the Vanderbilt Sports Concussion Center, and Benjamin Brett, a postdoctoral research fellow the Medical College of Wisconsin, told PsyPost. “As our paper showed, the association between concussion history and depression, which is often portrayed as a causal relationship, was influenced by additional factors. In reality, the amount of bodily or somatic complaints had a larger effect than the number of concussions sustained by former NFL athletes.”
  • The majority of people playing football in the United States are under the age of 14, and there has been little to no independent data evaluating the effectiveness of the helmets worn by youth players. That’s the why the release of youth football helmet ratings by the Virginia Tech Helmet Lab is a big deal. Data from the group’s studies of head impacts among youth football players allowed for the creation of test methods that reflect the types of impacts young players actually experience on the field, according to Virginia Tech News. Seven helmet models earned five stars — the highest possible rating — and the rest earned three or four. The ratings include every youth football helmet currently on the market, and every company had at least one five-star model. Click here for the results.
  • A recent report in Walla Walla, Wash.’s Union-Bulletin notes that acupuncture may be one way to treat concussion symptoms. “With concussions — and almost any injury — acupuncture needles are first inserted at the opposite end of the body from the injury. With a concussion, that means the ankles, tops of the feet, and hands,” wrote licensed acupuncturist Lindsey Thompson. “The theory behind this is that points farthest away from the site of injury have the strongest influence on that injury. Specific points on the feet and hands are clinically indicated for use with various conditions that happen on the face, head, neck and shoulders. These points have been passed down in writing for a few thousand years.”
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