BrainScope TBI
by BrainScope Company
· Based in United States →
— AI-Powered EEG Solutions for Brain Injury Assessment
Contact for pricing
Regulatory Status Disclosed
Overview
BrainScope TBI is a pioneering medical neurotechnology that leverages artificial intelligence (AI) and computational neuroscience to transform brain health assessment. It provides objective, diagnostic insights by analyzing brain electrical activity (EEG) to aid in the rapid evaluation of patients with mild traumatic brain injury (mTBI), including concussions and brain bleeds.
The device is a portable, non-invasive, handheld system that utilizes a rapid-application disposable electrode headset and a mobile-device interface. It processes EEG data using advanced digital signal processing and machine learning algorithms to deliver actionable biomarkers and classifier outputs. This technology is designed to assist physicians in emergency departments, urgent care clinics, and other point-of-care settings to quickly assess head-injured patients, potentially reducing unnecessary head CT scans and associated radiation exposure, and improving patient triage and management.
BrainScope’s solution includes the Structural Injury Classifier (SIC) to indicate the likelihood of structural brain injury visible on a CT scan, and the Brain Function Index (BFI) and Concussion Index (CI) to provide objective markers of brain function impairment and aid in concussion evaluation and recovery monitoring. It was the first device in neurology cleared by the FDA under the AI/Machine Learning-Enabled Medical Device category.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered EEG solutions
- Non-invasive and radiation-free assessment
- Portable and handheld point-of-care device
- Rapid assessment (under 20 minutes)
- Detects both structural (brain bleed) and functional (concussion) injuries
- Reduces unnecessary head CTs and radiation exposure
- Provides objective diagnostic insights
- Utilizes advanced digital signal processing and machine learning algorithms
- Disposable electrode headset for data capture
- Offers Brain Function Index (BFI) and Concussion Index (CI)
Use Cases
- Triage of mild traumatic brain injury (mTBI) in Emergency Departments
- Assessment of head-injured patients in Urgent Care Clinics
- Concussion management and monitoring (e.g., athletes, military personnel)
- Aid in evaluating the need for head CT scans
- Objective assessment of brain bleeds
- Objective assessment of concussions and functional brain impairment
Details
| Category | Clinical Decision Support & Reference, Neurology AI, Triage & ER/ICU AI |
| Pricing | Contact for pricing |
| Deployment | Portable point-of-care EEG assessment system (disposable headset + mobile interface) with a cloud-based EEG-to-biomarker analytics platform. |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated BrainScope TBI (K190815) was FDA cleared on September 11, 2019, as a multi-modal, multi-parameter assessment aid for patients aged 18-85 with a closed head injury (GCS 13-15) within 72 hours, to aid in evaluating the need for a CT scan for structural brain injury and assessing concussion/mTBI. |
| Integrations | |
| EHR | Not specified |
| Specialties | Emergency Medicine, Neurology, Sports Medicine |
Ratings & Reviews
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Press & Coverage
BrainScope Company, Inc.
BrainScopeu00ae Announces Publication of Findings From Three Years of Concussion Studies in Football Players
BrainScope announced the publication of findings from two clinical studies on collegiate and high school football players who sustained concussions, suggesting their technology can detect TBI, categorize severity, and indicate recovery time. The studies, published in 'Brain Injury' and 'Journal of Head Trauma Rehabilitation,' highlight the BrainScope TBI-Index as a potential objective indicator for injury, recovery, and return to play.
2021-02
accessdata.fda.gov
BrainScope TBI (Model - accessdata.fda.gov)
This FDA document outlines the indications for use of the BrainScope TBI (Model: Ahead 400), a multi-modal assessment tool for closed head injuries in patients aged 18-85 with a GCS score of 13-15, who are being considered for a head CT. It clarifies that the device should not be used as a substitute for a CT scan.
2019-02
FDA
K190815 - 510(k) Premarket Notification - FDA
This FDA 510(k) Premarket Notification details the BrainScope TBI (Model: Ahead 500) and its substantial equivalence to the predicate device (Ahead 400). It specifies the device's use as an adjunct to standard clinical practice for evaluating patients with closed head injuries and GCS scores of 13-15.
2019-09
PMC
Artificial intelligence in neurology: opportunities, challenges, and policy implications - PMC
This peer-reviewed article discusses the role of AI in neurology, highlighting BrainScope TBI as a diagnostic support tool for closed head injuries. It notes BrainScope's Concussion Index, which uses EEG, neurocognitive measures, and clinical symptoms to estimate the likelihood of structural brain injury.
2024-03
BioWorld
Outpatient final leaves several device makers in the cold for new tech pass-through payment
A BioWorld article reports that BrainScope Inc. was denied new technology pass-through (NTPT) payments for its BrainScope TBI algorithm in the 2023 hospital outpatient final rule. The Centers for Medicare & Medicaid Services (CMS) stated the handheld component could be used on multiple patients, making it ineligible.
2022-11
PMC
The power of publicu2013private partnership in medical technology innovation: Lessons from the development of FDA-cleared medical devices for assessment of concussion - PMC
This article discusses the role of public-private partnerships in medical technology innovation, specifically mentioning BrainScope Company, Inc. and its early data presented to the DOD's Combat Casualty Care Research Program regarding mTBI identification. It notes BrainScope's FDA 510(k) clearances for its TBI assessment devices.
2022-03
BrainScope Company, Inc.
BrainScope Announces Publication Demonstrating High Accuracy For Identification of Acute Stroke
BrainScope announced the publication of an independent study in 'Academic Emergency Medicine' demonstrating the potential clinical utility of its TBI technology to identify acute stroke. The study showed high sensitivity (92%) for identifying acute stroke using BrainScope's proprietary TBI algorithms.
2015-09
BrainScope Company, Inc.
BrainScope Announces Publication of Independent, Prospective Validation Study Demonstrating High Accuracy For Identification of Traumatic Intracranial Hematomas
BrainScope announced the publication of an independent study validating its technology's ability to identify traumatic intracranial hematomas in the Emergency Department. The study demonstrated high sensitivity for detecting these injuries non-invasively and without radiation, suggesting a potential paradigm shift in TBI emergency medicine.
2015-08
Videos
Product demos, reviews, and walkthroughs for BrainScope TBI.
BrainScope One for Head Injury & TBI
Village Chiropractic
Frequently Asked Questions
BrainScope TBI employs advanced AI and machine learning algorithms to process real-time electroencephalogram (EEG) data collected via a handheld device and disposable headset. These algorithms identify objective biomarkers of structural and functional mild traumatic brain injuries (mTBI), including brain bleeds and concussions, within minutes.
BrainScope TBI has received multiple FDA clearances for its devices and algorithms, notably being the first AI/Machine Learning-Enabled Medical Device cleared by the FDA in Neurology. This demonstrates a thorough vetting of its technology and adherence to regulatory processes for brain health assessment.
BrainScope TBI offers a rapid, radiation-free, point-of-care assessment that can help rule out the need for a head CT scan for brain bleeds, which traditional methods often rely on. Unlike CT scans, BrainScope's AI-powered algorithms also objectively assess for concussion and brain function impairment.
While specific pricing details are not publicly disclosed, studies indicate that integrating BrainScope TBI can lead to significant cost reductions for healthcare systems and patients. This is achieved by potentially reducing unnecessary head CT scans by up to 31% and decreasing patient length of stay in emergency departments.
BrainScope TBI is indicated for specific patient populations, generally adults aged 18-85 (or 13-25 for the Concussion Index) who have sustained a head injury within a certain timeframe, typically 72 hours. It serves as an adjunct to standard clinical practice and should not be used as a substitute for a CT scan when clinically indicated.
BrainScope's website privacy policy indicates that personal information collected through its website is handled with care, and for research studies, data collection and processing are subject to informed consent and applicable contracts. While specific device-level data privacy protocols are not detailed, the company emphasizes its commitment to human brain health and regulatory adherence.
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| Last Verified: 2026-04-20 | First Added: 2026-04-20