Traumatic Brain Injury (TBI)

FDA warns public not to use unapproved or uncleared medical devices to help assess or diagnose a concussion

U.S. Food & Drug Administration – Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI.

FDA takes new step to help advance the development of novel treatments for traumatic brain injury with the qualification of a medical device development tool

FDA – the U.S. Food and Drug Administration qualified the OsiriX CDE Software Module, from the TBI Endpoints Development Initiative. This is the third qualification of a medical device development tool (MDDT) by the FDA, and the first of a biomarker test tool type.