BrainScope One

JSON twin: https://www.healthaidb.com/software/brainscope-one.json

Company Name

BrainScope

Product URL

https://www.brainscope.com/products

Company URL

https://www.brainscope.com/

Categories

• clinical Care
• diagnostic Support
• patient Facing
• emergency Care
• neurology
• medical Device
• point-of-care
• clinical Decision Support
• Clinical
• Diagnostic
• Emergency Medicine
• Medical Devices
• Point-of-care Testing
• Trauma Care
• Concussion Management
• Brain Injury Assessment

Summary

BrainScope One is a handheld, FDA-cleared device that uses EEG-based technology to rapidly and objectively assess brain injuries, including concussions and brain bleeds, at the point of care.

Description

BrainScope One is a non-invasive, portable device designed to assist healthcare professionals in the rapid assessment of traumatic brain injuries (TBI), including concussions and brain bleeds. Utilizing electroencephalogram (EEG) technology, it provides objective data to aid in clinical decision-making, potentially reducing unnecessary head CT scans and associated radiation exposure. The device is intended for use in emergency departments, urgent care clinics, and other healthcare settings for patients aged 18 to 85 years within three days of a head injury. It is not a replacement for CT scans but serves as a decision support tool to guide further evaluation. BrainScope One has received multiple FDA clearances and is backed by an extensive intellectual property portfolio. The company has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and the device is currently being utilized by the U.S. military both domestically and internationally. Additionally, BrainScope One is used in various market segments, including urgent care and occupational health clinics, concussion clinics, hospital emergency rooms, university sports and student health centers, professional sports, and pharmaceutical clinical trials.

Api Available

unknown

Certifications

• FDA 510(k)
• ISO 13485:2003
• CE Mark
• ONC Health IT Certification
• ISO 27001

Company Founding

2006

Company Offices

• United States
• Canada
• United Kingdom
• Germany
• France
• Italy
• Spain
• Australia
• Japan
• South Korea

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485:2003
• SOC 2
• ISO 27001

Customers

Data Residency

US-only

Data Standards

• HL7 v2
• DICOM
• ICD-10
• SNOMED CT

Deployment Model

• on_prem
• SaaS

Features

• EEG-based brain injury assessment
• Non-invasive and pain-free for patients aged 18-85 within 3 days post-injury
• Measures brain electrical activity and neurocognitive function
• Provides objective data panels for clinical diagnosis
• Integrates advanced digital signal processing and sophisticated algorithms
• Utilizes miniaturized hardware and disposable headset sensors
• FDA-cleared medical device
• ISO 13485:2003 Certification
• Potential to reduce unnecessary head CT scans by one-third
• Potential to reduce head injury referrals to emergency departments by up to 75%
• Potential to reduce healthcare costs for payers and patients by over 30%
• Supports integration into existing urgent care clinic workflows
• Enhances operational efficiencies in urgent care settings
• Offers new economic opportunities for urgent care centers
• Backed by the U.S. Department of Defense for TBI assessment technology development
• Recipient of the GE-NFL Head Health Challenge I award
• Recipient of the Frost & Sullivan Best Practices Award in Traumatic Brain Injury Assessment Solutions Market
• Nominated for the Prix Galien Best Medical Technology award

Id

SW0543

Integration Partners

Integrations

• Emergency Department Information Systems (EDIS)
• Electronic Health Records (EHR)
• Picture Archiving and Communication Systems (PACS)

Languages Supported

• English
• Spanish
• French
• German
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Hebrew
• Hindi
• Bengali
• Punjabi
• Tamil
• Telugu
• Marathi
• Gujarati

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB
• Consumer

Optional Modules

• Ocular assessment module

Os Platforms

• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Consent Management
• Data Anonymization
• Data Minimization

Product Code

SW0543

Product Name

BrainScope One

Ratings

Regions Available

• United States
• Canada
• Europe
• Australia
• New Zealand
• Japan
• South Korea
• India
• China
• Brazil
• Mexico
• Argentina
• Chile
• Colombia
• Peru
• South Africa
• Egypt
• Saudi Arabia
• United Arab Emirates
• Israel

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

""

Security Features

• Encryption
• Role-Based Access Control (RBAC)
• Single Sign-On (SSO)
• Audit Logs
• Two-Factor Authentication (2FA)

Specialties

• Emergency Medicine
• Neurology
• Sports Medicine
• Orthopedics
• Pediatrics
• Geriatrics
• Trauma Surgery
• Rehabilitation Medicine
• Neurosurgery
• Physical Medicine And Rehabilitation
• Family Medicine
• Internal Medicine

Support Channels

System Requirements

iOS 10+, Android 5.0+, Windows 10+, macOS 10.12+, Linux kernel 4.4+

Target Users

• Clinicians
• Nurses
• Patients
• Admins
• Payers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "BrainScope One",
  "company_name": "BrainScope",
  "product_url": "https://www.brainscope.com/products",
  "company_url": "https://www.brainscope.com/",
  "related_urls": [
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  ],
  "product_code": "SW0543",
  "summary": "BrainScope One is a handheld, FDA-cleared device that uses EEG-based technology to rapidly and objectively assess brain injuries, including concussions and brain bleeds, at the point of care.",
  "description": "BrainScope One is a non-invasive, portable device designed to assist healthcare professionals in the rapid assessment of traumatic brain injuries (TBI), including concussions and brain bleeds. Utilizing electroencephalogram (EEG) technology, it provides objective data to aid in clinical decision-making, potentially reducing unnecessary head CT scans and associated radiation exposure. The device is intended for use in emergency departments, urgent care clinics, and other healthcare settings for patients aged 18 to 85 years within three days of a head injury. It is not a replacement for CT scans but serves as a decision support tool to guide further evaluation. BrainScope One has received multiple FDA clearances and is backed by an extensive intellectual property portfolio. The company has partnered with the U.S. Department of Defense for the development of its TBI assessment technology, and the device is currently being utilized by the U.S. military both domestically and internationally. Additionally, BrainScope One is used in various market segments, including urgent care and occupational health clinics, concussion clinics, hospital emergency rooms, university sports and student health centers, professional sports, and pharmaceutical clinical trials.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "emergency Care",
    "neurology",
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    "point-of-care",
    "clinical Decision Support",
    "Clinical",
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    "Patient-facing",
    "Emergency Medicine",
    "Neurology",
    "Medical Devices",
    "Point-of-care Testing",
    "Trauma Care",
    "Concussion Management",
    "Brain Injury Assessment"
  ],
  "market_segment": [
    "Enterprise",
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  ],
  "target_users": [
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    "Nurses",
    "Patients",
    "Admins",
    "Payers"
  ],
  "specialties": [
    "Emergency Medicine",
    "Neurology",
    "Sports Medicine",
    "Orthopedics",
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    "Geriatrics",
    "Trauma Surgery",
    "Rehabilitation Medicine",
    "Neurosurgery",
    "Physical Medicine And Rehabilitation",
    "Family Medicine",
    "Internal Medicine"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Europe",
    "Australia",
    "New Zealand",
    "Japan",
    "South Korea",
    "India",
    "China",
    "Brazil",
    "Mexico",
    "Argentina",
    "Chile",
    "Colombia",
    "Peru",
    "South Africa",
    "Egypt",
    "Saudi Arabia",
    "United Arab Emirates",
    "Israel"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hebrew",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Tamil",
    "Telugu",
    "Marathi",
    "Gujarati"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Canada",
    "United Kingdom",
    "Germany",
    "France",
    "Italy",
    "Spain",
    "Australia",
    "Japan",
    "South Korea"
  ],
  "company_founding": "2006",
  "deployment_model": [
    "on_prem",
    "SaaS"
  ],
  "os_platforms": [
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "EEG-based brain injury assessment",
    "Non-invasive and pain-free for patients aged 18-85 within 3 days post-injury",
    "Measures brain electrical activity and neurocognitive function",
    "Provides objective data panels for clinical diagnosis",
    "Integrates advanced digital signal processing and sophisticated algorithms",
    "Utilizes miniaturized hardware and disposable headset sensors",
    "FDA-cleared medical device",
    "ISO 13485:2003 Certification",
    "Potential to reduce unnecessary head CT scans by one-third",
    "Potential to reduce head injury referrals to emergency departments by up to 75%",
    "Potential to reduce healthcare costs for payers and patients by over 30%",
    "Supports integration into existing urgent care clinic workflows",
    "Enhances operational efficiencies in urgent care settings",
    "Offers new economic opportunities for urgent care centers",
    "Backed by the U.S. Department of Defense for TBI assessment technology development",
    "Recipient of the GE-NFL Head Health Challenge I award",
    "Recipient of the Frost & Sullivan Best Practices Award in Traumatic Brain Injury Assessment Solutions Market",
    "Nominated for the Prix Galien Best Medical Technology award"
  ],
  "optional_modules": [
    "Ocular assessment module"
  ],
  "integrations": [
    "Emergency Department Information Systems (EDIS)",
    "Electronic Health Records (EHR)",
    "Picture Archiving and Communication Systems (PACS)"
  ],
  "data_standards": [
    "HL7 v2",
    "DICOM",
    "ICD-10",
    "SNOMED CT"
  ],
  "api_available": "unknown",
  "system_requirements": "iOS 10+, Android 5.0+, Windows 10+, macOS 10.12+, Linux kernel 4.4+",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485:2003",
    "SOC 2",
    "ISO 27001"
  ],
  "certifications": [
    "FDA 510(k)",
    "ISO 13485:2003",
    "CE Mark",
    "ONC Health IT Certification",
    "ISO 27001"
  ],
  "security_features": [
    "Encryption",
    "Role-Based Access Control (RBAC)",
    "Single Sign-On (SSO)",
    "Audit Logs",
    "Two-Factor Authentication (2FA)"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Consent Management",
    "Data Anonymization",
    "Data Minimization"
  ],
  "data_residency": "US-only",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "\"\"",
  "integration_partners": [],
  "id": "SW0543",
  "slug": "brainscope-one",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/brainscope-one.json"
  }
}