Avoid Using Unapproved Devices To Diagnose Concussions, FDA Warns

Federal regulators are warning consumers about the risks they may face from unapproved devices that may be marketed for the diagnosis of concussions.

In a safety alert issued on April 10, the FDA urges consumers to be wary of concussion diagnosis devices which do not require doctor supervision, because some may lead to further harm.

The FDA identified several companies that are manufacturing and marketing devices as concussion diagnosis tools. However, the devices have not been approved by the FDA and have not been shown to be safe, effective or accurate.

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This includes any product claiming to assess and diagnose brain injury or concussion. The devices claim this is done by measuring changes in brain function after a head injury by having the injured person perform tests on a smartphone or tablet-based app to determine a change in cognitive status. This includes changes to vision, concentration, memory, balance, and speech.

The products that are not FDA approved are being marketed to parents of injured children, athletic coaches, and health care providers. They are being used to assess, diagnose, and manage head injuries without the oversight of a trained doctor.

The FDA is working to raise public awareness about the serious risk they may face from using these devices following a head injury. If a person is injured and uses one of these devices, but the device indicates no concussion, the person may resume normal activities instead of getting necessary medical care. This could cause further injury or harm.

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release. “Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger.”

The FDA has approved a limited number of devices to diagnose or treat head injuries. None of these are approved for use without a doctor’s supervision.

The devices that have been approved by the FDA to diagnose concussion include the Brain Trauma Assessment Kit, the BrainScope series of devices, the impact tests, the Infrascanner and the EyeBox.

The devices work in a number of different ways, Banyan BTI’s Brain Trauma Assesmsnt Kit is a blood-based test which uses biomarkers’ to indicate brain injuries. The ImPACT devices are computerized tests used to assess cognitive function after possible concussion.

Head injuries can result in brain damage after only a single blow to the head. Recent research has linked concussions to increased incidence of depression, higher risk of suicide, and trouble the risk of death from unintentional injury.

Any person who believes they may have suffered a concussion after a head injury should always seek treatment by a doctor.


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