Rule out the likelihood of intracranial hemorrhage & assess concussion severity in under 20 minutes

The BrainScope® device is an FDA cleared, handheld medical device and decision support tool that uses AI and machine learning technology to identify objective biomarkers of structural and functional brain injury in patients with suspected mild traumatic brain injury (mTBI). Using EEG signals to power its algorithms, BrainScope enables EDs to triage mTBI at the point of care without radiation and with a 30%-60% demonstrated potential reduction in unnecessary head CTs.

The device is the only FDA cleared, comprehensive, rapid, and radiation-free assessment of intracranial hemorrhage and concussion.

Combining real time handheld technology and advances in brain electrical activity signal processing, BrainScope uses machine learning algorithm methodologies to derive physiological biomarkers of brain injury at the point of care.

The handheld medical device rapidly collects high quality brain electrical activity data using a disposable electrode headset from forehead locations and limited related symptoms, and then processes the data using the previously derived FDA cleared algorithms.

Device outputs aid clinicians to objectively rule out brain bleed and determine concussion status quickly and accurately.

BrainScope can be administered by anyone on the healthcare team, under physician order.

BrainScope assessments are appropriate for low to mid acuity patients presenting to all levels of emergency departments, urgent care centers, concussion clinics, as well as patients in point of injury situations on the sports sideline or at military post. BrainScope is an “all-comer” test. The assessments can be reliably used with head injured patients under the influence of drugs and/or alcohol (found in 30-50% of head injured ED patients) and with patients on blood thinners. Indications for patient use include:

Structural Injury (brain bleed)

• BrainScope Structural Injury Classifier (SIC): GCS 13-15, 18-85 years of age, within 72 hours
• Digitized PECARN: GCS 14-15, 2-17 years of age, within 24 hours

Brain Function Impairment (concussion)

• BrainScope Concussion Index (CI): GCS 15, 13-25 years of age, within 72 hours
• BrainScope Brain Function Index (BFI): GCS 13-15, 18-85 years of age, within 72 hours

BrainScope is not intended as a stand-alone diagnostic or to be used as a substitute for a head CT scan. 

Head Injury Triage

Using the handheld device assists clinicians to rule out a brain bleed at the point of care and potentially reduce unnecessary head CT scans and associated radiation exposure. It has been clinically demonstrated and reported that when using BrainScope in the ED, 30%-60% of head CTs could be avoided in patients age 18-85 presenting with a head injury.

BrainScope’s rapid structural and functional assessments can result in improvements in emergency department throughput from reduced patient wait-times. Clinical experience has demonstrated up to a 50% improvement in patient length of stay. The digitized PECARN capability provides convenient access to the current gold standard in pediatric head injury assessment for referral to CT.

Importantly, for the first time clinicians have a powerful, objective tool that provides significant insight into both structural injury and concussion status, enabling better and more informed follow up care and management for concussed patients. In-device and PDF reports can be provided to the patient prior to discharge, and can lead to higher overall patient satisfaction and confidence in their treatment.

Concussion Assessment

BrainScope’s Concussion Index (CI) and Brain Function Index (BFI) are FDA cleared objective markers that identify the likelihood of concussion, with brain electrical activity at the core. They provide an objective marker of brain function impairment and scale with clinical severity.

Digitized SCAT, MACE 2, and neurocognitive performance tests complement BrainScope’s algorithms and can be added as desired by the clinician to aid in making a clinical diagnosis.

PDF reports include all assessments in one report. 

BrainScope’s assessments aid in providing the answers patients need when faced with a head injury—Is there a brain bleed? Am I concussed? BrainScope is the first and only cleared medical device that provides an objective and accurate assessment for both brain bleed and concussion.

BrainScope can potentially result in avoidance of unnecessary radiation exposure associated with the use of CT, is performed at the point of care reducing hours of wait time, and can help get concussed patients referred for appropriate care. With BrainScope, patients get the answers they need in a fraction of the time.

For patients ages 18-85 years, the BrainScope Structural Injury Classifier (SIC) indicates the likelihood of being negative for brain bleed on a CT scan and identifies the need for further evaluation. The SIC has demonstrated sensitivity of 99% and negative predictive value (NPV) of 98% for acute traumatic intracranial bleeds (CT+) > 1mL of blood. For the pediatric population ages 2-17 years, the BrainScope device offers a digitized Pediatric Emergency Care Applied Research Network (PECARN) Decision Rule. The digitized PECARN aids in the evaluation of suspected mTBI to identify a child's risk of a clinically significant TBI.

The BrainScope Brain Function Index (BFI) provides an objective marker of brain function impairment (concussion) and that scales with severity of functional impaitment at the time of injury (within 72 hours). The BFI enables timely informed referrals and continuity of care and may lead to improved patient outcomes, satisfaction, Merit-based Incentive Payment System (MIPS) compliance, and Hospital Consumer Assessment of Healthcare Providers and Systems (HCAHPS) survey results. The BFI is indicated for patients 18-85 years of age.

The BrainScope Concussion Index (CI) provides an objective measure to aid in the evaluation of concussion. The CI algorithm uses EEG at its core. The CI may be used to assess patients at time of injury to aid the clinician in making referral pathway and readiness to return to activity decisions. The CI is indicated for the pediatric and young adult population, 13-25 years of age.

BrainScope is a multimodal device that in addition to its FDA cleared algorithms contains configurable digitized clinical assessment tools, including the SCAT5 and MACE 2 (for the military, which includes the SAC, VOMs and mBESS), as well as a number of neurocognitive performance tests on the device, so a clinician can perform a comprehensive assessment with one device and have point of care results immediately available for all assessments performed.

With features such as a single use and mask-friendly 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. The handheld device may be cleaned using a 70% isopropyl alcohol disinfectant. Hospital grade cleaning wipes such as CaviWipes™ and Sani-Cloth® may also be used. Further, BrainScope can help minimize time in the ED, and therefore risk of exposure, for those who do not require CT testing.

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