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The FDA and Traumatic Brain Injuries: Research and Assessment

January 10, 2017

Traumatic brain injuries (TBIs) are caused by a jarring force that impacts or twists the brain inside of a person’s skull. Commonly associated with concussions (which are technically a mild type of TBI), a TBI can range from mild to severe. Less serious brain injuries—such as most concussions—often show symptoms such as confusion and headaches. Meanwhile, more damaging head injuries can lead to vomiting, persistent headaches, loss of motor skills, or even in some severe cases, death. According to the Centers for Disease Control and Prevention (CDC), approximately 2.5 million emergency room visits are related to traumatic brain injuries each year, and emergency department visits associated with TBIs increased by 70% between 2001 and 2010. Because of the ongoing growth in TBIs, it remains vitally important to be aware of current diagnostic methods for brain injuries as well as trends in new research regarding assessment tools.

While most mild head injuries, such as concussions, do not always lead to more serious conditions, the United States Food and Drug Administration (FDA) continues to monitor new research, tests, and treatments related to brain injuries in addition to performing their own research into diagnostic assessments for TBIs.

One thing we already know is that the assessment of a brain injury can sometimes be the most important step in making sure that a person receives the best medical care possible. Brain injuries can be difficult to diagnose without adequate testing since they may not present any outward evidence of injury or trauma to the naked eye. The FDA is currently performing research into the usefulness of tests for diagnosing TBIs, including CT scans and electroencephalography (EEG), which looks at electrical pulses across the brain and monitors for any unusual activity.

In the case of moderate and severe brain injuries, surgery can become a critical necessity, often to repair ruptured blood vessels in the head. This is just one reason why early assessment and diagnosis of a TBI is crucial. Thankfully, the FDA continues to focus its efforts on researching and approving new technology that makes faster and better assessments possible.

New Tools and Research

One such new technology is known as ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing), which is a device produced by ImPACT Applications, Inc. of Pittsburgh, Pennsylvania. ImPACT and (and its equivalent for children ages 5 through 11, ImPACT Pediatric) allow trained health professionals to assess cognitive function using skill tests that assess performance on key measurements like word memory and reaction time. The results are then compared to a baseline score, helping to quickly tell whether or not the patient needs further tests to monitor for brain injuries.

As of August 22, 2016, the FDA approved marketing of the ImPACT and ImPACT Pediatric devices. However, the FDA makes it clear that these tools are not meant to diagnose brain injuries; instead, they are only meant to function as preliminary assessment tools. They also caution that while this test is fast and easy to use, the results should only be interpreted by a trained health professional.

Nonetheless, it is encouraging to see that new research and innovations are being applied to the field of traumatic brain injuries. Whether they arise from being hit in the head during a football game or getting into a car accident, brain injuries continue to frustrate medical experts’ efforts to understand them fully. What we do know beyond a doubt, however, is that these injuries have an enormous and sometimes devastating impact on the people they affect.

The FDA has made their interest in solving this problem clear, whether by approving new technologies such as ImPACT, or by involving themselves in research to better understand how to use diagnostic tools, including CT scans and EEGs. With so many discoveries coming out in the wake of these new technologies and studies, the public and health care professionals alike should keep an eye out for new reports from the FDA and related sources. As we go forward, new tools and research can help move us toward the goal of successfully diagnosing and treating every traumatic brain injury.

Be Informed and Receive Great Legal Help

Here at the Law Office of William D. Cook, we want you to be as informed as possible. We make it our mission to provide you with important information that will help you make the best decisions about your health and legal situation.

With a long history of litigating personal injury cases involving traumatic brain injuries, we have the knowledge and experience to help you with your personal injury claim. We offer free consultations so we can listen to the details of your situation and provide you with candid legal advice about your best course of action, and we handle all personal injury cases on a contingent-fee basis, which means that you won’t pay attorney’s fees unless we make a recovery on your behalf.

If you have been injured because of someone else’s carelessness, don’t wait—call our offices now at (800) 757-7757 or fill out our convenient online contact form.


FDA allows marketing of first-of-kind computerized cognitive tests to help assess cognitive skills after a head injury. (2016, August 22). U.S. Food and Drug Administration. Retrieved from

NINDS traumatic brain injury information page. (2016, September 8). National Institute of Neurological Disorders and Stroke. Retrieved from

TBI: Get the facts. (2016, January 22). Centers for Disease Control and Prevention. Retrieved from

Traumatic brain injury: FDA research and actions. (2016, September 8). U.S. Food and Drug Administration. Retrieved from


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