Rapid test for brain injury gets FDA breakthrough status
A rapid test for traumatic brain injuries (TBI) capable of confirming a concussion in less than 90 seconds has received FDA’s breakthrough device status. The designation for BioDirection’s test is intended to speed development, assessment, and review of a device.
The test, called the Tbit platform, uses a nanotechnology-based sensor to measure protein biomarkers that are released from the brain into the bloodstream immediately after head trauma. The system includes a small portable analyzer and a single-use disposable cartridge that can detect small amounts of biomarkers in a drop of blood.
A faster diagnosis for brain injury can support the most appropriate treatment decisions and reduce unnecessary head CT scans, the company said.
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