FDA grants breakthrough designation to BioDirection Tbit System

Divya Tirumalaraju 12 February 2019 (Last Updated February 12th, 2019 10:13)

The US Food and Drug Administration (FDA) has awarded breakthrough device designation to medical device firm BioDirection’s Tbit System developed to predict positive computerised tomography (CT) scans after traumatic brain injury (TBI).

FDA grants breakthrough designation to BioDirection Tbit System
The company is engaged in the development of fast point-of-care products for the objective diagnosis and management of concussion and other TBI.

The US Food and Drug Administration (FDA) has awarded breakthrough device designation to medical device firm BioDirection’s Tbit System developed to predict positive computerised tomography (CT) scans after traumatic brain injury (TBI).

Tbit comprises a nanotechnology biosensor to quickly identify and accurately measure protein biomarkers released from the brain immediately after a trauma to the head.

It is claimed to feature ultra-high sensitivity and delivers objective results within 90 seconds.

“BioDirection said that the portability of the device enables initial testing in the emergency department, with potential for future use at the point-of-injury.”

BioDirection executive chairman James Wylie said: “The Tbit System 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 three to four hours or more and require serum testing in a central laboratory.”

BioDirection said that the portability of the device enables initial testing in the emergency department, with potential for future use at the point-of-injury.

The company added that earlier diagnosis of a brain injury could facilitate more appropriate treatment decisions, at the same time potentially minimising unnecessary head CT scans.

BioDirection founder and chief technical officer Brian McGlynn noted: “Blunt trauma injuries that impact the head and brain require the rapid identification of comorbidities to rule out or confirm the potential of intracranial haemorrhage that may require some form of surgical intervention.

“The Tbit System has the potential to deliver actionable information to the physician where minutes matter. Longer term, our technology has the potential to support a full continuum of care ranging from stratification of injury, prognosis and return to play and activity.”

The company is engaged in the development of fast point-of-care products for the objective diagnosis and management of concussion and other TBI.

Around one million people in the UK visit A&E departments due to TBI each year.

Additional reporting by Charlotte Edwards.