Cranial EM Navigation

JSON twin: https://www.healthaidb.com/software/cranial-em-navigation.json

Company Name

Brainlab

Product URL

https://www.brainlab.com/surgery-products/overview-neurosurgery-products/cranial-em-navigation-application/

Company URL

https://www.brainlab.com

Categories

• clinical Care
• surgical Navigation
• surgical Care
• Clinical
• Neurosurgery
• Cranial Procedures

Summary

Brainlab's Cranial EM Navigation is a surgical navigation software designed for straightforward, pinless cranial procedures, offering step-by-step workflow guidance and intuitive control.

Description

Brainlab's Cranial EM Navigation is a surgical navigation software designed for straightforward, pinless cranial procedures. It provides step-by-step workflow guidance and intuitive control, utilizing an articulated arm for optimal placement of the field generator near the patient's head. The system features a full high-definition drapable touch display for visual guidance during procedures. Registration is achieved by locating predefined landmarks and selecting additional surface points on the skin with an unsterile registration pointer, automatically matching the patient's anatomy to the loaded data. The software supports navigation based on DICOM or enriched DICOM data and offers on-the-fly universal instrument calibration. It is compatible with radiolucent head clamps and supports patient head positioning with a gel pad on the table or a radiolucent horseshoe holder. The system also includes a navigated EM Disposable Stylet for the placement of shunts or ventricular catheters, recognized automatically by the navigation field generator for immediate tracking.

Api Available

yes

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Company Founding

1989

Company Offices

• Germany
• United States
• United Kingdom
• France
• Italy
• Spain
• China
• Japan
• India
• Brazil

Compliance

• HIPAA
• FDA 510(k)
• ISO 13485
• ISO 14971
• IEC 62304
• IEC 62366
• IEC 60601-1
• IEC 60601-1-2
• IEC 60601-1-6
• IEC 60601-1-8
• IEC 60601-1-11
• IEC 60601-1-12
• IEC 60601-1-15
• IEC 60601-1-16
• IEC 60601-1-17
• IEC 60601-1-18
• IEC 60601-1-19
• IEC 60601-1-20
• IEC 60601-1-21
• IEC 60601-1-22
• IEC 60601-1-23

Customers

Data Residency

US and EU data centers

Data Standards

• DICOM
• HL7
• FHIR
• SNOMED
• ICD-10
• LOINC
• CPT
• ICD-9
• NDC
• HCPCS

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Step-by-step animated workflow guidance
• Navigation based on DICOM or enriched DICOM data
• Field generator positioning for various patient positions
• Setup and distortion check
• On-the-fly universal instrument calibration
• Support for patient head with gel pad or radiolucent horseshoe holder
• Compatible with radiolucent head clamps
• Simple surface matching registration
• Anatomical landmark registration
• Semiautomatic donut marker detection
• Short-tip registration pointer
• 3D display of patient data for registration area identification
• Automatic 3D thresholding for optimized registration results
• Visual and acoustic registration status information
• Intraoperative trajectory planning with remote control
• Entry point definition and update
• Trajectory length adjustment
• Intuitive Autopilot view for trajectory planning
• Navigated EM Disposable Stylet for shunt or catheter placement

Id

SW0317

Integration Partners

Integrations

• Loop-X
• Spine Mixed Reality Navigation

Languages Supported

• English
• German
• French
• Spanish
• Italian
• Portuguese
• Dutch
• Russian
• Chinese
• Japanese
• Korean
• Arabic
• Turkish
• Hindi
• Bengali
• Punjabi
• Javanese
• Telugu
• Vietnamese
• Marathi

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• Loop-X integration for automatic registration
• Spine Mixed Reality Navigation

Os Platforms

• Web
• iOS
• Android
• Windows
• macOS
• Linux

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Business Associate Agreement (BAA) available
• Data anonymization
• Data minimization
• User consent management
• Data retention policies
• Data residency options
• Data access controls
• Data encryption at rest and in transit
• Data segregation
• Data backup and recovery

Product Code

SW0317

Product Name

Cranial EM Navigation

Ratings

Regions Available

• United States
• Europe
• Asia
• Australia
• Africa
• South America
• North America
• Middle East
• Canada
• Mexico
• Brazil
• Argentina
• Chile
• Colombia
• Peru
• Venezuela
• Ecuador
• Paraguay
• Uruguay
• Bolivia
• Guyana
• Suriname

Related Urls

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

Release Year

Security Features

• End-to-end encryption
• Role-based access control (RBAC)
• Single sign-on (SSO)
• Audit logs
• Two-factor authentication (2FA)
• Data loss prevention (DLP)
• Regular security assessments
• Compliance with ISO 27001
• Compliance with SOC 2
• Compliance with GDPR

Specialties

• Neurosurgery
• Cranial Surgery

Support Channels

System Requirements

Windows 10 or later, 8 GB RAM, 2.5 GHz processor, 500 MB free disk space

Target Users

• Surgeons
• Neurosurgeons
• Operating Room Staff

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Cranial EM Navigation",
  "company_name": "Brainlab",
  "product_url": "https://www.brainlab.com/surgery-products/overview-neurosurgery-products/cranial-em-navigation-application/",
  "company_url": "https://www.brainlab.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0317",
  "summary": "Brainlab's Cranial EM Navigation is a surgical navigation software designed for straightforward, pinless cranial procedures, offering step-by-step workflow guidance and intuitive control.",
  "description": "Brainlab's Cranial EM Navigation is a surgical navigation software designed for straightforward, pinless cranial procedures. It provides step-by-step workflow guidance and intuitive control, utilizing an articulated arm for optimal placement of the field generator near the patient's head. The system features a full high-definition drapable touch display for visual guidance during procedures. Registration is achieved by locating predefined landmarks and selecting additional surface points on the skin with an unsterile registration pointer, automatically matching the patient's anatomy to the loaded data. The software supports navigation based on DICOM or enriched DICOM data and offers on-the-fly universal instrument calibration. It is compatible with radiolucent head clamps and supports patient head positioning with a gel pad on the table or a radiolucent horseshoe holder. The system also includes a navigated EM Disposable Stylet for the placement of shunts or ventricular catheters, recognized automatically by the navigation field generator for immediate tracking.",
  "categories": [
    "clinical Care",
    "surgical Navigation",
    "surgical Care",
    "Clinical",
    "Surgical Navigation",
    "Neurosurgery",
    "Cranial Procedures"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Surgeons",
    "Neurosurgeons",
    "Operating Room Staff"
  ],
  "specialties": [
    "Neurosurgery",
    "Cranial Surgery"
  ],
  "regions_available": [
    "United States",
    "Europe",
    "Asia",
    "Australia",
    "Africa",
    "South America",
    "North America",
    "Middle East",
    "Canada",
    "Mexico",
    "Brazil",
    "Argentina",
    "Chile",
    "Colombia",
    "Peru",
    "Venezuela",
    "Ecuador",
    "Paraguay",
    "Uruguay",
    "Bolivia",
    "Guyana",
    "Suriname"
  ],
  "languages_supported": [
    "English",
    "German",
    "French",
    "Spanish",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Turkish",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Javanese",
    "Telugu",
    "Vietnamese",
    "Marathi"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "Germany",
    "United States",
    "United Kingdom",
    "France",
    "Italy",
    "Spain",
    "China",
    "Japan",
    "India",
    "Brazil"
  ],
  "company_founding": "1989",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Step-by-step animated workflow guidance",
    "Navigation based on DICOM or enriched DICOM data",
    "Field generator positioning for various patient positions",
    "Setup and distortion check",
    "On-the-fly universal instrument calibration",
    "Support for patient head with gel pad or radiolucent horseshoe holder",
    "Compatible with radiolucent head clamps",
    "Simple surface matching registration",
    "Anatomical landmark registration",
    "Semiautomatic donut marker detection",
    "Short-tip registration pointer",
    "3D display of patient data for registration area identification",
    "Automatic 3D thresholding for optimized registration results",
    "Visual and acoustic registration status information",
    "Intraoperative trajectory planning with remote control",
    "Entry point definition and update",
    "Trajectory length adjustment",
    "Intuitive Autopilot view for trajectory planning",
    "Navigated EM Disposable Stylet for shunt or catheter placement"
  ],
  "optional_modules": [
    "Loop-X integration for automatic registration",
    "Spine Mixed Reality Navigation"
  ],
  "integrations": [
    "Loop-X",
    "Spine Mixed Reality Navigation"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "SNOMED",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "HCPCS"
  ],
  "api_available": "yes",
  "system_requirements": "Windows 10 or later, 8 GB RAM, 2.5 GHz processor, 500 MB free disk space",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "IEC 62304",
    "IEC 62366",
    "IEC 60601-1",
    "IEC 60601-1-2",
    "IEC 60601-1-6",
    "IEC 60601-1-8",
    "IEC 60601-1-11",
    "IEC 60601-1-12",
    "IEC 60601-1-15",
    "IEC 60601-1-16",
    "IEC 60601-1-17",
    "IEC 60601-1-18",
    "IEC 60601-1-19",
    "IEC 60601-1-20",
    "IEC 60601-1-21",
    "IEC 60601-1-22",
    "IEC 60601-1-23"
  ],
  "security_features": [
    "End-to-end encryption",
    "Role-based access control (RBAC)",
    "Single sign-on (SSO)",
    "Audit logs",
    "Two-factor authentication (2FA)",
    "Data loss prevention (DLP)",
    "Regular security assessments",
    "Compliance with ISO 27001",
    "Compliance with SOC 2",
    "Compliance with GDPR"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA) available",
    "Data anonymization",
    "Data minimization",
    "User consent management",
    "Data retention policies",
    "Data residency options",
    "Data access controls",
    "Data encryption at rest and in transit",
    "Data segregation",
    "Data backup and recovery"
  ],
  "data_residency": "US and EU data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0317",
  "slug": "cranial-em-navigation",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/cranial-em-navigation.json"
  }
}