FDA raised concern on Wednesday about devices and apps marketed to consumers that claim to help assess, diagnose, or manage a head injury, including concussion and traumatic brain injury. Only a limited number of devices have received the agency's blessing to date and all of them require an evaluation by a healthcare professional.
“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. 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,” said Jeffrey Shuren, MD, director of FDA’s Center for Devices and Radiological Health.
Shuren said the agency alerted companies to its concerns and asked them to remove such claims.
FDA said the products 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 (cognitive) status including vision, concentration, memory, balance, and speech. Parents and coaches should make sure athletes seek treatment right away from a healthcare professional if any head injury is suspected.
The agency warned that it will continue to monitor promotional materials and claims about these and similar products and contact companies that violate the law. If the companies in question do not address FDA's concerns, the agency said it will consider additional enforcement actions if appropriate.
Here are a few devices that have received FDA clearance or approval for concussion or TBI:
Banyan Biomarkers' blood-based Banyan Brain Trauma Indicator test.
The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices from Pittsburgh, PA-based ImPACT Applications. The ImPACT devices are computerized tools used to test a person's cognitive function after a possible concussion.
Oculogica's EyeBox concussion test, designed to remove some of the guesswork from concussion assessment. This test does not rely on a baseline measurement for comparison.