• FDA sounds alarm on unregulated brain injury devices

    • April 12, 2019
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    While FDA has approved a number of new concussion and traumatic brain injury (TBI) assessment tools in recent years, the agency noted that none of those legally marketed devices are indicated for use without evaluation and assistance from a healthcare provider.

    “I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own,” FDA device center chief Jeff Shuren said in the 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.”

    Devices greenlighted by FDA, from five different listed manufacturers, most recently include the De Novo-cleared EyeBox, which tracks eye movement to measure cranial nerve function, as well as an expanded version of 510(k)-cleared BrainScope One, a portable point-of-care device system involving an electrode headset and a practitioner’s handheld electroencephalogram signal (EEG) recording device, aiming to capture and evaluate certain brain electrical activity biomarkers of TBIs.


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