FDA grants breakthrough status to a brain injury detection system

The U.S. Food & Drug Administration (FDA) has granted breakthrough device status to the Tbit Platform test developed by the Boston-based medical device firm BioDirection. This basically means that representatives from these two organisations will meet more often to speed up the testing and approval process.

The device consists of a portable analyser that uses a nanotechnology-based sensor to measure biomarkers released by the brain after a head trauma and intracranial haemorrhage. It takes only 90 seconds to get the results, and a faster diagnosis will help doctors to decide on the best treatment option, and the number of unnecessary head CT scans will be reduced as well. And if the FDA approves the device, it could initially be used in emergency room settings, and later on in the stratification of injury and prognosis stages of treatment.