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New TBI test designated as breakthrough device by FDA

On Behalf of | Feb 14, 2019 | Brain Injury |

A rapid test for confirming traumatic brain injuries has received the FDA’s designation as a breakthrough device. The test, called the Tbit™ Blood Testing Platform and developed by medical device company BioDirection, can diagnose a concussion in less than 90 seconds using nanotechnology-based sensors. West Virginia residents will want to know more.

What is involved is a portable analyzer and a single-use disposable cartridge. Using a single drop of blood in that cartridge, the sensors can detect any protein biomarkers that are released from the brain and into the bloodstream in the wake of head trauma. The benefits of this rapid test include support for the most appropriate treatment options and avoidance of unnecessary CT scans.

This comes at a time when new technology is continually expanding the ways that TBIs can be diagnosed. For instance, the FDA has authorized the marketing of a device called EyeBOX, which uses eye tracking to measure cranial nerve function and assess the severity of TBIs. The company BrainScope has developed a portable system for measuring electrical activity biomarkers that might give signs of a TBI.

TBIs are a major concern in the U.S., contributing at approximately 30 percent of all deaths resulting from injuries. TBIs were behind 2.8 million emergency department visits in 2013, the CDC says. Falls, car crashes and sports-related incidents frequently end in TBI.

Those who incur a TBI risk brain damage. In any case, they will be left with medical expenses, lost wages and perhaps a diminished capacity to earn a living. If they were not to blame for the incident that led to the TBI, then they may be able to file a personal injury claim against the negligent party and be compensated for these losses. This is where a lawyer might come in handy, so victims may wish to consult with one.