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July 29, 2020

Brain Injury Assessment

Conversation with Industry: BrainScope

This content is written by the company and does not represent the opinions of ACEP.

Rapid, Accurate Assessment of mTBI Patients at Point of Care


BrainScope’s advanced AI and machine learning technology identifies objective markers of structural and functional mild traumatic brain injuries (mTBI) in under 20 minutes. Using EEG signals to power its algorithms, BrainScope enables EDs to triage mTBI at the point of care without radiation and with a 30.8% demonstrated potential reduction in unnecessary head CTs. The device is the only FDA-approved, comprehensive, rapid, and radiation-free assessment of brain bleed and concussion.

The BrainScope Structural Injury Classifier (SIC) detects the presence of blood and predicts the likelihood that the patient would be CT-positive. Sensitivity to even the smallest amount of detectable blood is 99%, with a negative predictive value (NPV) of 98%. False negatives in the FDA validation study were 2%, none of which were clinically significant, required neurosurgery, or returned to the hospital within 96 hours, and all were GCS 15. In a recent publication using the SIC in the ED, there was 100% sensitivity and no false negatives reported.

The BrainScope Brain Function Index (BFI) provides an objective marker of brain function impairment that enables timely referrals and continuity of care and may lead to improved patient outcome, satisfaction, MIPS compliance, and HCAHP survey results.

Intended patient population: 18-85 years of age, GCS of 13-15, and for use within 72 hours of mild head injury. BrainScope is not intended as a stand-alone diagnostic or to be used as a replacement for a CT scan. For a list of complete indications please visit our products page.


ED Throughput and Efficiency with BrainScope


Video: Brain Bleed, Concussion, or Both?


FAQ: BrainScope in the ED

What evidence do you have that BrainScope will be effective in the ED?

BrainScope is shown to have a 99% sensitivity to CT-positive brain injuries and 98% negative predictive value (NPV). A study published by Washington University’s Barnes Jewish Medical Center demonstrated that using the FDA-cleared BrainScope in the ED resulted in a potential 30.8% reduction in the overall number of head CTs. In addition to clinical validation of the Structural Injury Classifier in 11 different EDs, BrainScope technology is rooted in:

  • 8 FDA Clearances
  • 10 years of R&D
  • 29 clinical publications
  • 10,000+ subject observations

What patient value does BrainScope deliver in the ED?

BrainScope’s rapid structural and functional assessments result in the patient spending significantly less overall time in the ED (1 -3 hours vs 6 hours). Using the point-of-care, handheld device can reduce unnecessary head CT scans and the associated radiation exposure for 30.8% of ED patients presenting with mTBI. With BrainScope, patients can feel confident they are leaving the ED with an objective, A.I. driven report, and the necessary treatment referral, and follow up plans.

How will use of BrainScope in the ED benefit clinical staff?

Throughput time in the ED is significantly less using BrainScope as a rapid, objective assessment of mTBI patients when compared to head CT. The under 20-minute assessment results in 50-80% total time saved compared to national averages for head CT. With features such as a single use and mask-friendly EEG headset, eight peel and stick electrodes, easily cleaned and glove-capable handheld device, BrainScope provides an intuitive experience while reducing risk of infection and transmission.


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