Ahead 200

JSON twin: https://www.healthaidb.com/software/ahead-200.json

Company Name

BrainScope

Product URL

https://www.brainscope.com/

Company URL

https://www.brainscope.com/

Categories

• clinical Care
• diagnostic Support
• patient Facing
• Clinical
• Diagnostic

Summary

BrainScope's Ahead 200 is a handheld device that uses smartphone technology to assess traumatic brain injuries by recording and analyzing electroencephalographs (EEGs).

Description

The Ahead 200 device leverages commercial smartphone hardware and a custom sensor to record and analyze EEGs, providing an interpretation of the brain's structural condition after a head injury. It is indicated as an adjunct to standard clinical practice for evaluating patients considered for a head CT scan, particularly those who have sustained a closed head injury within 24 hours and present with mild symptoms. The device was developed in collaboration with the U.S. Army Medical Research and Materiel Command's Combat Casualty Care Research Program and received FDA 510(k) clearance in May 2015. It is intended for use in urgent care settings to aid in the rapid assessment of traumatic brain injuries, potentially improving triage, reducing unnecessary CT scans, and decreasing healthcare costs. The device is not a substitute for a CT scan and is intended for use in conjunction with other clinical tools. It is designed for patients aged 18-80 years who have sustained a closed head injury within 24 hours and present with mild symptoms. The Ahead 200 is a smaller, more rugged, and modernized version of BrainScope's previous Ahead 100 device, which was cleared by the FDA in November 2014. The device has been utilized in various clinical studies, including those involving concussed athletes in collegiate sports, to assess its effectiveness in real-world settings. BrainScope has received significant funding from the U.S. Department of Defense for the development of its traumatic brain injury assessment technology, totaling over $27 million. The company holds 86 issued and pending patents related to its technology and has received significant funding from private investors to accelerate its development efforts. BrainScope's mission is to develop objective, non-invasive, patient-friendly assessment devices for rapid and easy use in urgent care settings, aiming to improve the early identification, staging, and triage of head-injured patients.

Api Available

no

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• IEC 60601
• IEC 62304
• IEC 62366
• IEC 61010
• IEC 61000
• IEC 61010-1
• IEC 61010-2-101

Company Founding

2006

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• IEC 60601
• IEC 62304
• IEC 62366
• IEC 61010
• IEC 61000
• IEC 61010-1
• IEC 61010-2-101

Customers

• U.S. Department of Defense
• National Football League (NFL)
• University of Virginia School of Medicine
• University sports programs
• Emergency departments across the U.S.

Data Residency

US-based data centers

Data Standards

• HL7
• DICOM
• ICD-10
• SNOMED CT
• LOINC
• CPT
• FHIR
• CDA
• C-CDA
• NCPDP

Deployment Model

• on_prem

Features

• Real-time EEG recording and analysis
• Non-invasive brain injury assessment
• FDA-cleared for traumatic brain injury evaluation
• Portable and rugged design
• User-friendly interface for healthcare professionals
• Rapid assessment of brain function post-injury
• Integration with standard clinical practices
• Battery-operated for field use
• Wireless data transmission capabilities
• Compact and lightweight for easy handling
• Durable construction for medical environments
• Quick setup and operation
• Clinical decision support tools
• Data storage for patient records
• Real-time data visualization
• Patient monitoring during assessment
• Automated reporting features
• Customizable settings for different clinical scenarios
• Compliance with medical device regulations
• Support for multiple languages

Id

SW0627

Integration Partners

• Google Android operating system
• University of Virginia School of Medicine
• University sports programs
• Emergency departments across the U.S.

Integrations

• Hospital Information Systems
• Electronic Health Records (EHR)
• Clinical Decision Support Systems
• Telemedicine Platforms
• Mobile Health Applications
• Patient Monitoring Devices
• Laboratory Information Systems
• Medical Imaging Systems
• Patient Data Management Systems
• Clinical Workflow Management Tools

Languages Supported

• English

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• consumer

Optional Modules

• Advanced data analytics module
• Cloud-based data storage integration
• Telemedicine integration for remote consultations
• Patient data management system
• Clinical workflow optimization tools
• Integration with hospital information systems
• Mobile application for patient data access
• Remote monitoring capabilities
• Integration with electronic health records (EHR)
• Patient engagement tools

Os Platforms

• Android

Pricing Details

contact vendor

Pricing Model

contact vendor

Privacy Features

• Data anonymization
• Patient consent management
• Data minimization
• Secure data storage
• Compliance with data protection regulations
• User data access controls
• Data retention policies
• Data sharing policies
• Patient data access logs
• Data breach notification procedures

Product Code

SW0627

Product Name

Ahead 200

Ratings

• FDA clearance for adjunctive assessment of traumatic brain injury

Regions Available

• United States

Related Urls

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

Release Year

2015

Security Features

• Data encryption at rest and in transit
• Role-based access control (RBAC)
• Secure wireless communication protocols
• Audit trails for user activities
• Two-factor authentication (2FA)
• Secure boot process
• Data anonymization
• Regular security updates
• Compliance with medical device security standards
• User authentication mechanisms

Specialties

• Neurology
• Emergency Medicine

Support Channels

• email
• phone
• chat
• ticketing
• community
• 24x7

System Requirements

• Android OS
• Bluetooth-enabled devices
• Wi-Fi connectivity
• USB charging port
• Minimum 2 GB RAM
• Minimum 16 GB storage
• Touchscreen display
• Built-in camera
• Built-in microphone
• Built-in speaker

Target Users

• clinicians
• patients

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• The Ahead 200 device offers a non-invasive and objective assessment of traumatic brain injury, which is crucial in urgent care settings.
• Its integration with Android smartphones makes it user-friendly and accessible for medical professionals.
• The device's ability to rapidly identify and categorize patients with mild symptoms but potential life-threatening TBI has the potential to improve triage and save lives.
• The collaboration with the Department of Defense has led to significant advancements in the device's development and clinical studies.
• The FDA clearance of the Ahead 200 represents a significant achievement in BrainScope’s mission to develop an objective, non-invasive, patient-friendly assessment device.

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Ahead 200",
  "company_name": "BrainScope",
  "product_url": "https://www.brainscope.com/",
  "company_url": "https://www.brainscope.com/",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0627",
  "summary": "BrainScope's Ahead 200 is a handheld device that uses smartphone technology to assess traumatic brain injuries by recording and analyzing electroencephalographs (EEGs).",
  "description": "The Ahead 200 device leverages commercial smartphone hardware and a custom sensor to record and analyze EEGs, providing an interpretation of the brain's structural condition after a head injury. It is indicated as an adjunct to standard clinical practice for evaluating patients considered for a head CT scan, particularly those who have sustained a closed head injury within 24 hours and present with mild symptoms. The device was developed in collaboration with the U.S. Army Medical Research and Materiel Command's Combat Casualty Care Research Program and received FDA 510(k) clearance in May 2015. It is intended for use in urgent care settings to aid in the rapid assessment of traumatic brain injuries, potentially improving triage, reducing unnecessary CT scans, and decreasing healthcare costs. The device is not a substitute for a CT scan and is intended for use in conjunction with other clinical tools. It is designed for patients aged 18-80 years who have sustained a closed head injury within 24 hours and present with mild symptoms. The Ahead 200 is a smaller, more rugged, and modernized version of BrainScope's previous Ahead 100 device, which was cleared by the FDA in November 2014. The device has been utilized in various clinical studies, including those involving concussed athletes in collegiate sports, to assess its effectiveness in real-world settings. BrainScope has received significant funding from the U.S. Department of Defense for the development of its traumatic brain injury assessment technology, totaling over $27 million. The company holds 86 issued and pending patents related to its technology and has received significant funding from private investors to accelerate its development efforts. BrainScope's mission is to develop objective, non-invasive, patient-friendly assessment devices for rapid and easy use in urgent care settings, aiming to improve the early identification, staging, and triage of head-injured patients.",
  "categories": [
    "clinical Care",
    "diagnostic Support",
    "patient Facing",
    "Clinical",
    "Diagnostic",
    "Patient-facing"
  ],
  "market_segment": [
    "enterprise",
    "consumer"
  ],
  "target_users": [
    "clinicians",
    "patients"
  ],
  "specialties": [
    "Neurology",
    "Emergency Medicine"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "contact vendor",
  "pricing_details": "contact vendor",
  "license": "commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2006",
  "deployment_model": [
    "on_prem"
  ],
  "os_platforms": [
    "Android"
  ],
  "features": [
    "Real-time EEG recording and analysis",
    "Non-invasive brain injury assessment",
    "FDA-cleared for traumatic brain injury evaluation",
    "Portable and rugged design",
    "User-friendly interface for healthcare professionals",
    "Rapid assessment of brain function post-injury",
    "Integration with standard clinical practices",
    "Battery-operated for field use",
    "Wireless data transmission capabilities",
    "Compact and lightweight for easy handling",
    "Durable construction for medical environments",
    "Quick setup and operation",
    "Clinical decision support tools",
    "Data storage for patient records",
    "Real-time data visualization",
    "Patient monitoring during assessment",
    "Automated reporting features",
    "Customizable settings for different clinical scenarios",
    "Compliance with medical device regulations",
    "Support for multiple languages"
  ],
  "optional_modules": [
    "Advanced data analytics module",
    "Cloud-based data storage integration",
    "Telemedicine integration for remote consultations",
    "Patient data management system",
    "Clinical workflow optimization tools",
    "Integration with hospital information systems",
    "Mobile application for patient data access",
    "Remote monitoring capabilities",
    "Integration with electronic health records (EHR)",
    "Patient engagement tools"
  ],
  "integrations": [
    "Hospital Information Systems",
    "Electronic Health Records (EHR)",
    "Clinical Decision Support Systems",
    "Telemedicine Platforms",
    "Mobile Health Applications",
    "Patient Monitoring Devices",
    "Laboratory Information Systems",
    "Medical Imaging Systems",
    "Patient Data Management Systems",
    "Clinical Workflow Management Tools"
  ],
  "data_standards": [
    "HL7",
    "DICOM",
    "ICD-10",
    "SNOMED CT",
    "LOINC",
    "CPT",
    "FHIR",
    "CDA",
    "C-CDA",
    "NCPDP"
  ],
  "api_available": "no",
  "system_requirements": [
    "Android OS",
    "Bluetooth-enabled devices",
    "Wi-Fi connectivity",
    "USB charging port",
    "Minimum 2 GB RAM",
    "Minimum 16 GB storage",
    "Touchscreen display",
    "Built-in camera",
    "Built-in microphone",
    "Built-in speaker"
  ],
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "IEC 60601",
    "IEC 62304",
    "IEC 62366",
    "IEC 61010",
    "IEC 61000",
    "IEC 61010-1",
    "IEC 61010-2-101"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "IEC 60601",
    "IEC 62304",
    "IEC 62366",
    "IEC 61010",
    "IEC 61000",
    "IEC 61010-1",
    "IEC 61010-2-101"
  ],
  "security_features": [
    "Data encryption at rest and in transit",
    "Role-based access control (RBAC)",
    "Secure wireless communication protocols",
    "Audit trails for user activities",
    "Two-factor authentication (2FA)",
    "Secure boot process",
    "Data anonymization",
    "Regular security updates",
    "Compliance with medical device security standards",
    "User authentication mechanisms"
  ],
  "privacy_features": [
    "Data anonymization",
    "Patient consent management",
    "Data minimization",
    "Secure data storage",
    "Compliance with data protection regulations",
    "User data access controls",
    "Data retention policies",
    "Data sharing policies",
    "Patient data access logs",
    "Data breach notification procedures"
  ],
  "data_residency": "US-based data centers",
  "customers": [
    "U.S. Department of Defense",
    "National Football League (NFL)",
    "University of Virginia School of Medicine",
    "University sports programs",
    "Emergency departments across the U.S."
  ],
  "user_reviews": [
    "The Ahead 200 device offers a non-invasive and objective assessment of traumatic brain injury, which is crucial in urgent care settings.",
    "Its integration with Android smartphones makes it user-friendly and accessible for medical professionals.",
    "The device's ability to rapidly identify and categorize patients with mild symptoms but potential life-threatening TBI has the potential to improve triage and save lives.",
    "The collaboration with the Department of Defense has led to significant advancements in the device's development and clinical studies.",
    "The FDA clearance of the Ahead 200 represents a significant achievement in BrainScope’s mission to develop an objective, non-invasive, patient-friendly assessment device."
  ],
  "ratings": [
    "FDA clearance for adjunctive assessment of traumatic brain injury"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2015",
  "integration_partners": [
    "Google Android operating system",
    "University of Virginia School of Medicine",
    "University sports programs",
    "Emergency departments across the U.S."
  ],
  "id": "SW0627",
  "slug": "ahead-200",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/ahead-200.json"
  }
}