FDA Warns Against Using Medical Devices to Help Assess or Diagnose a Concussion Unless It Has Been ‘Cleared or Approved’

The U.S. Food and Drug Administration (FDA) warned consumers last month to be cautious about “certain products intended to aid in the assessment, diagnosis, or management of a head injury, which includes concussion, traumatic brain injury (TBI), and mild traumatic brain injury (mild TBI or mTBI).”   Elaborating, it noted that such products “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 determ