BrainScope is the only FDA cleared non-invasive medical device that objectively assesses head injured patients for both brain bleeds & concussions at point of care.
Demonstrated potential to reduce head CT in the ED by 30%-60%“Utilizing BrainScope gives me more actionable clinical data to assess concussion than is available to emergency physicians in the ED today."
Marsh Cuttino, MD FAAEM FACEP, Emergency Physician, Richmond VA
"When BrainScope is used independently or in conjunction with a standard head rule, fewer patients are scanned—resulting in less radiation exposure, less time in the ED, improved patient experience."
David Levine, MD, FACEP, Emergency Physician, Brunswick OH
“BrainScope gives our patients peace of mind—with BrainScope, we have saved 43% of patients from unnecessary radiation due to CT scans. ”
Mark Christensen, MD, Regional Director, Alteon Emergency Medicine - North Alabama
Naunheim R, Konstantinovic Koscso M, Poirier R. Reduction in unnecessary CT scans for head injury in the emergency department using an FDA cleared device. American Journal of Emergency Medicine. 2019 Oct;37(10):1987-1988. doi: 10.1016/j.ajem.2019.04.037
Article Info
Emergency Department (ED) visits for mild Traumatic Head Injury (mTBI) have greatly increased due to more awareness of potential consequences of such injuries. While the vast majority (>80%) of mTBI patients who go to the ED receive a head CT scan, >90% of them are found to be negative. This practice unnecessarily exposes these patients to radiation, increases the use of ED resources, and lengthens throughput times. The integration of reliable, objective predictors of intracranial injury for making important initial assessment decisions can impact significantly on this practice.
Clay, M. Clinical Utility of an EEG Based Biomarker for the Triage of Head Injured Patients in the ED: INOVA Pilot Study. White Paper, 2021.
White Paper Info
Within one rapid EEG test at the point of care, BrainScope provides objective data on both brain bleeds and concussions to assist healthcare providers in evaluating head injured patients. This study was successful in determining utilization, staff assessment, and patient experience of the BrainScope technology in daily use. The results of the trial were overwhelmingly positive.
Demonstrated 99% accuracy in identifying the likelihood of the smallest detectable level of blood (>1 mL).
Determine concussion status at same time with same setup and recording.
A patient with mild traumatic brain injury is a person who has had a traumatically induced physiological disruption of brain function, as manifested by at least one of the following:
1. Any period of loss of consciousness;
2. Any loss of memory for events immediately before or after the accident;
3. Any alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused); and
4. Focal neurological deficit(s) that may or may not be transient; but where the severity of the injury does not exceed the following: loss of consciousness of approximately 30 minutes or less; after 30 minutes, an initial Glasgow Coma Scale (GCS) of 13–15; and post traumatic amnesia (PTA) not greater than 24 hours.
This definition includes:
1. The head being struck,
2. The head striking an object, and
3. The brain undergoing an acceleration/deceleration movement (i.e., whiplash) without direct external trauma to the head.
Ref : www.acrm.org
FDA cleared AI/machine learning derived advanced pattern recognition algorithms are used to determine the likelihood of structural and functional brain injury with high independently validated accuracy.
Hanley D, Prichep LS, Bazarian J, Huff JS, Naunheim R, Garrett J, Jones E, Wright DW, O'Neill J, Badjatia N, Gandhi D, Curley K, Chiacchierini R, O'Neil B, Hack D. Emergency Department Triage of Traumatic Head Injury Using Brain Electrical Activity Biomarkers: A Multisite Prospective Observational Validation Trial. Academic Emergency Medicine. 2017; 24(5):617-627.
Hanley D, Prichep LS, Badjatia N, Bazarian J, Chiacchierini R, Curley K, Garrett J, Jones E, Naunheim R, O'Neil B, O'Neill J, Wright DW, Huff JS. A Brain Electrical Activity (EEG) Based Biomarker of Functional Impairment in Traumatic Head Injury: A Multisite Validation Trial. Journal of Neurotrauma. 2018; 35(1):41-47.
Bazarian J, Elbin R, Casa D, Hotz G, Neville C, Lopez R, Schnyer D, Yeargin S, Covassin T. Validation of a Machine Learning Brain Electrical Activity-Based Index to Aid in Diagnosing Concussion Among Athletes. JAMA Network Open. 2021;4(2) e2037349.
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