Research & Development
BioDirection awarded US FDA breakthrough device designation for Tbit System to predict positive CT scans following traumatic brain injury
12 February 2019 -

Medical device company BioDirection Inc revealed on Monday the receipt of US Food and Drug Administration (FDA) Breakthrough Device Designation for Tbit System for the prediction of positive computerised tomography (CT) scans following Traumatic Brain Injury (TBI).

The US FDA Breakthrough Devices Programme (BDP) will reportedly provide the patients and health care providers with timely access to designated medical devices by speeding up their development, assessment and review.

According to the company, the Tbit System uses a patented nanotechnology biosensor to rapidly detect and accurately measure protein biomarkers that are released from the brain immediately following a head trauma. The portable system allows for testing to be initially performed in the emergency department and eventually, after receipt of further US FDA clearances, at the point-of-injury.

In conjunction, the earlier diagnosis of a brain injury can support more appropriate treatment decisions while potentially reducing unnecessary head CT scans and the company's lead product, the Tbit System, delivers biologically-based results shown to accurately confirm a concussion in less than 90 seconds.



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