Medical Devices for the Assessment of Traumatic Brain Injury

Traumatic Brain Injury (TBI) assessment has evolved with medical device innovations, offering tools that support clinical evaluations. The FDA regulates these devices, categorizing them based on risk levels, ranging from low-risk (Class I) to high-risk (Class III). Currently, 13 FDA-cleared devices assist in TBI assessments, utilizing methods such as neurocognitive testing, eye tracking, and blood-based biomarkers. While these devices enhance diagnostic accuracy, they are not standalone solutions and must be used alongside established clinical practices.