The US Food and Drug Administration (FDA) has awarded breakthrough device designation to medical device firm BioDirection’s Tbit System developed to predict positive computerised tomography (CT) scans after traumatic brain injury (TBI).
Tbit comprises a nanotechnology biosensor to quickly identify and accurately measure protein biomarkers released from the brain immediately after a trauma to the head.
It is claimed to feature ultra-high sensitivity and delivers objective results within 90 seconds.
For more information, visit: BioDirection
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