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# BioDirection Gains Breakthrough Designation for Tbit System
- URL: https://www.fdaweb.com/biodirection-gains-breakthrough-designation-for-tbit-system/
- Published: 2019-02-11T12:00:00.000Z
- Updated: 2026-09-15T01:02:23.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143348

FDA has granted BioDirection a breakthrough device designation for its Tbit System for the prediction of positive computerized tomography scans following a traumatic brain injury. The device is designed to measure the body’s response to trauma and provide a rapid point-of-care test result in less than two minutes from a single drop of blood, while current technology may run up to four hours or more and require serum testing in a central laboratory, the company says. It uses a nanotechnology biosensor to detect and 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 emergency departments and eventually the company says it plans to seek clearance for use at the point-of-injury.