We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Accept
  • SKIP TO CONTENT
  • SKIP NAVIGATION
  • Drug News
    • Trending
    • Commercial Operations
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Drug Daily Bulletin
    • Drug Industry Daily
  • Device News
    • Trending
    • Commercial Operations
    • Inspections and Audits
    • Postmarket Safety
    • Quality
    • Regulatory Affairs
    • Research and Development
    • Submissions and Approvals
    • FDAnews Device Daily Bulletin
    • FDAnews Device Daily Bulletin Premium
  • Books
    • FDAnews Books Library
    • Drug Books
    • Device Books
  • Training/Events
    • Webinar Training Pass
    • Events
  • Resources
    • Form 483s Database
    • FDA Approved Drugs
    • eCFR and Guidances
    • White Papers
  • CenterWatch
  • About Us
    • The Company
    • Contact Us
  • Advertising
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » FDA Clears First Blood Test for Concussion Detection

FDA Clears First Blood Test for Concussion Detection

ClearanceStamp_Blue.gif
February 15, 2018

The FDA granted marketing authorization to Banyan Biomarkers’ Brain Trauma Indicator — the first blood test for evaluating mild traumatic brain injuries, otherwise known as concussions,

The review and authorization, completed in less than six months, was expedited under the Breakthrough Devices Program in collaboration with the U.S. Defense Department.

The Banyan Brain Trauma Indicator measures neurologically released levels of proteins and it provides test results in no more than four hours to aid clinicians in determining whether to perform a CT scan in patients. The availability of the concussion blood test is expected to help reduce unnecessary brain CT scans and the association radiation exposure.

The FDA said the test has the potential to rule out the need for a CT scan in at least one-third patients who are suspected of having mild traumatic brain injuries.

View today's stories

Devices Submissions and Approvals

Upcoming Events

  • 04Apr

    Optimizing Quality Control Operations with Unified Quality

  • 12Apr

    The Patient Playbook Webinar Series, Part 3 — Rethinking the Development of Participant-Centric Clinical Trial Technology

  • 20Apr

    Medical Device Enforcement: Latest Developments from the FDA, DOJ and FTC

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 26Apr

    Building the Foundation for QMS AI

Featured Products

  • FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

    FDA’s New Quality System Regulation: Transitioning from QSR to ISO 13485

  • Selecting and Implementing Electronic Document Management Systems in the EU

    Selecting and Implementing Electronic Document Management Systems in the EU

Featured Stories

  • Surmodics Gets FDA’s Feedback on Rejected PMA

  • EU Approves Amicus Therapeutics Pombiliti for Late-Onset Pompe Disease

  • FDA Final Order Requires PMA for Spinal Spheres

  • FDA and Lupus Research Alliance Form Drug Development Consortium

The Revised ICH E8: A Guide to New Clinical Trial Requirements

Learn More
  • Drug Products
    • Quality
    • Regulatory Affairs
    • GMPs
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Device Products
    • Quality
    • Regulatory Affairs
    • QSR
    • Inspections and Audits
    • Postmarket Safety
    • Submissions and Approvals
    • Research and Development
    • Commercial Operations
  • Clinical Products
    • Trial Design
    • Data Integrity
    • GCP
    • Inspections and Audits
    • Transparency
  • Privacy Policy
  • Do Not Sell or Share My Data
Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 703.538.7600 – Toll free 888.838.5578

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing