Rule out the likelihood of a brain bleed & assess concussion severity in under 20 minutes

The BrainScope® device is an FDA cleared, handheld medical device and decision support tool that uses A.I. 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 31% demonstrated potential reduction in unnecessary head CTs.

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

Combining real time handheld technology and advances in EEG 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 EEG 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 in mTBI 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, at baseline, and over time
• 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, 31% of head CTs could be avoided in patients age 18-85 presenting with a head injury, with 100% sensitivity.

BrainScope’s rapid structural and functional assessments can result in improvements in ED throughput from reduced patient wait-times. (Modeling indicates 50-80% total time saved compared to national averages for throughput when a head CT is performed.) 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 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 Management

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. The BFI provides an objective marker of brain function impairment and scales with clinical severity.

The CI provides a stable measure from which change can be interpreted reliably over time, enabling a number of use cases: for baselining (particularly with athletes and military recruits), at time of injury, and to aid in return to activity decisions in both civilian and military settings. The CI provides an objective assessment, reflects severity at time of injury, and can be used to monitor and track recovery over time.

Digitized SCAT, MACE 2, and neurocognitive performance tests complement BrainScope’s algorithms for structural and functional injury assessments 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 rapid structural and functional brain injury 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 and often with less out of pocket expense.

For patients ages 18-85 years, the BrainScope Structural Injury Classifier (SIC) assesses for the likelihood of brain bleed and 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 longitudinally assess patients at baseline, time of injury, & recovery time points and to aid the clinician in making 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 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. 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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