SUBSCRIBE TO TMCnet
TMCnet - World's Largest Communications and Technology Community

TMC NEWS

TMCNET eNEWSLETTER SIGNUP

BioDirection Receives Breakthrough Device Designation from FDA for Tbit™ System
[February 11, 2019]

BioDirection Receives Breakthrough Device Designation from FDA for Tbit™ System


BOSTON, Feb. 11, 2019 /PRNewswire/ -- BioDirection, Inc., a privately held medical device company developing cutting-edge and rapid point-of-care products for the objective diagnosis and management of concussion and other acquired traumatic brain injuries, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the company's Tbit™ System for the prediction of positive computerized tomography (CT) scans following Traumatic Brain Injury (TBI).

According to the FDA, the goal of the Breakthrough Devices Program (BDP) is to provide patients and health care providers with timely access to designated medical devices by speeding up their development, assessment and review.  

"We are pleased to receive this FDA designation and believe it is a clear recognition of the potential advantages of the Tbit System over currently available technology," said James Wylie, executive chairman  of BioDirection. "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 2 minutes from a single drop of blood, while current technology may run 3-4 hours or more and require serum testing in a central laboratory."

The Tbit System uses a patented nanotechnology biosensor to rapidly detect and accurately 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 the emergency department and eventually, after receipt of further FDA clearances, at the point-of-injury. Earlier diagnosis of a brain injury can support more appropriate treatment decisions while potentially reducing unnecessary head CT scans.

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

About BioDirection, Inc.

BioDirection is a privately held medical device company developing novel and rapid point-of-care products for the objective diagnosis and management of concussion and other traumatic brain injury (TBI). The company's lead product, the Tbit™ System, delivers biologically-based results shown to accurately confirm a concussion in less than 90 seconds. BioDirection's platform system utilizes a patented bio-nanowire technology with the potential for use in a range of applications in point-of-care diagnostics. To learn more about BioDirection, visit http://www.biodirection.com   





Contact:


Adam Daley                                         

James A. Wylie, Executive Chairman

Berry & Company Public Relations     

BioDirection, Inc.

Tel: +1 (212) 253-8881                            

Tel: +1 (203) 240-1319

Email: adaley@berrypr.com               

Email: jwylie@biodirection.com  


Cision View original content:http://www.prnewswire.com/news-releases/biodirection-receives-breakthrough-device-designation-from-fda-for-tbit-system-300793034.html

SOURCE BioDirection, Inc.


[ Back To TMCnet.com's Homepage ]









Technology Marketing Corporation

35 Nutmeg Drive Suite 340, Trumbull, Connecticut 06611 USA
Ph: 800-243-6002, 203-852-6800
Fx: 203-866-3326

General comments: tmc@tmcnet.com.
Comments about this site: webmaster@tmcnet.com.

STAY CURRENT YOUR WAY

© 2019 Technology Marketing Corporation. All rights reserved | Privacy Policy