FDA warning against unregulated devices for concussion

17 April 2019

Last week the FDA warned against using medical devices purported to assess head injuries, stating that only five companies are cleared to market such devices in the US and that they should only be used by physicians.

“The FDA has identified several manufacturers that were marketing medical devices for concussion diagnosis, treatment or management without the FDA’s approval or clearance,” the FDA said. “To date, there are a limited number of medical devices that have been approved or cleared by the FDA to aid in diagnosis, treatment or management of head injury, including suspected concussion and other traumatic brain injuries.”

They also emphasised the lack of evidence for specific devices in their statement. “I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” the FDA said. “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 devices of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental status including vision, concentration, memory, balance and speech.

The FDA recommended that individuals should seek immediate treatment from a healthcare professional if they receive a head injury, including a concussion. The organisation also warned about potential future action if companies make claims about treating these conditions.



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