SpineUs System

JSON twin: https://www.healthaidb.com/software/spineus-system.json

Company Name

Verdure Imaging

Product URL

https://verdureimaging.com/spineus

Company URL

https://verdureimaging.com

Categories

• imaging Software
• medical Device
• ai Clinical Documentation Integrity
• clinical Decision Support
• clinical Care
• Diagnostic Imaging
• Medical Devices
• Artificial Intelligence
• Non-invasive Imaging
• Spinal Care

Summary

SpineUs™ is an AI-powered 3D ultrasound system developed by Verdure Imaging, designed to provide non-invasive, radiation-free spinal imaging for enhanced diagnostic precision and patient outcomes.

Description

SpineUs™ is the first FDA-cleared, AI-enabled 3D ultrasound imaging device specifically designed for spinal care. It offers real-time, non-invasive imaging without radiation exposure, enabling accurate assessment of spinal alignment and deformities. The system integrates advanced artificial intelligence to deliver precise 3D visualizations, supporting clinicians in diagnosis and treatment planning. SpineUs™ is compact, easy to use, and seamlessly integrates into existing clinical workflows, enhancing patient engagement and satisfaction. It is suitable for various applications, including mass screening and continuous monitoring, and is backed by established reimbursable spinal imaging codes, making it a cost-effective solution for healthcare providers.

Api Available

unknown

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

Company Founding

2015

Company Offices

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

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

Customers

Data Residency

US and EU data centers

Data Standards

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

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• AI-driven 3D spinal imaging
• Non-invasive imaging without radiation exposure
• Real-time spinal alignment visualization
• Portable and easy-to-use design
• Enhanced patient engagement through clear visuals
• Improved diagnostic accuracy for better treatment planning
• Cost-effective solution with established reimbursable codes
• Continuous monitoring and assessment capabilities
• Broad applications including mass screening and treatment effectiveness
• Seamless integration into existing healthcare practices

Id

SW0145

Integration Partners

Integrations

• Electronic Health Records (EHR)
• Picture Archiving and Communication System (PACS)
• Hospital Information System (HIS)
• Laboratory Information System (LIS)
• Clinical Decision Support Systems (CDSS)
• Telemedicine platforms
• Patient portals
• Billing systems
• Scheduling software
• Medical device interfaces

Languages Supported

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

Last Updated

2025-10-11

License

commercial

Market Segment

• enterprise
• smb

Optional Modules

• Advanced analytics
• Cloud storage integration
• Telehealth support
• Patient data management
• Automated reporting
• Mobile app integration
• Multi-user collaboration tools
• Customizable imaging protocols
• Patient education resources
• Remote diagnostics support

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

subscription

Privacy Features

• Business Associate Agreement (BAA)
• Patient consent management
• Data anonymization
• Data minimization
• Data retention policies
• Access controls
• Audit trails
• Data masking
• User authentication
• Secure data storage

Product Code

SW0145

Product Name

SpineUs System

Ratings

Regions Available

• United States
• Canada
• Europe
• Asia
• Australia
• New Zealand
• South America
• Africa
• Middle East
• India
• China
• Japan
• South Korea
• Singapore
• Malaysia
• Thailand
• Indonesia
• Philippines
• Vietnam
• Pakistan

Related Urls

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

Release Year

Security Features

• Data encryption
• Role-based access control (RBAC)
• Single sign-on (SSO)
• Audit logs
• Two-factor authentication (2FA)
• Data loss prevention (DLP)
• Secure data transmission
• User authentication
• Session management
• Access controls

Specialties

• Orthopedics
• Neurology
• Pediatrics
• Geriatrics
• Sports Medicine
• Rheumatology
• Physiotherapy
• Chiropractic
• Rehabilitation
• Pain Management
• Surgery
• Radiology
• Family Medicine
• Internal Medicine
• Emergency Medicine
• Occupational Therapy
• Osteopathy
• Sports Science

Support Channels

System Requirements

Web browser, iOS or Android device, Windows or macOS computer, Linux server

Target Users

• clinicians
• nurses
• patients
• admins

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "SpineUs System",
  "company_name": "Verdure Imaging",
  "product_url": "https://verdureimaging.com/spineus",
  "company_url": "https://verdureimaging.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0145",
  "summary": "SpineUs™ is an AI-powered 3D ultrasound system developed by Verdure Imaging, designed to provide non-invasive, radiation-free spinal imaging for enhanced diagnostic precision and patient outcomes.",
  "description": "SpineUs™ is the first FDA-cleared, AI-enabled 3D ultrasound imaging device specifically designed for spinal care. It offers real-time, non-invasive imaging without radiation exposure, enabling accurate assessment of spinal alignment and deformities. The system integrates advanced artificial intelligence to deliver precise 3D visualizations, supporting clinicians in diagnosis and treatment planning. SpineUs™ is compact, easy to use, and seamlessly integrates into existing clinical workflows, enhancing patient engagement and satisfaction. It is suitable for various applications, including mass screening and continuous monitoring, and is backed by established reimbursable spinal imaging codes, making it a cost-effective solution for healthcare providers.",
  "categories": [
    "imaging Software",
    "medical Device",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "clinical Care",
    "Diagnostic Imaging",
    "Medical Devices",
    "Artificial Intelligence",
    "Non-invasive Imaging",
    "Spinal Care"
  ],
  "market_segment": [
    "enterprise",
    "smb"
  ],
  "target_users": [
    "clinicians",
    "nurses",
    "patients",
    "admins"
  ],
  "specialties": [
    "Orthopedics",
    "Neurology",
    "Pediatrics",
    "Geriatrics",
    "Sports Medicine",
    "Rheumatology",
    "Physiotherapy",
    "Chiropractic",
    "Rehabilitation",
    "Pain Management",
    "Surgery",
    "Radiology",
    "Family Medicine",
    "Internal Medicine",
    "Emergency Medicine",
    "Occupational Therapy",
    "Osteopathy",
    "Sports Science"
  ],
  "regions_available": [
    "United States",
    "Canada",
    "Europe",
    "Asia",
    "Australia",
    "New Zealand",
    "South America",
    "Africa",
    "Middle East",
    "India",
    "China",
    "Japan",
    "South Korea",
    "Singapore",
    "Malaysia",
    "Thailand",
    "Indonesia",
    "Philippines",
    "Vietnam",
    "Pakistan"
  ],
  "languages_supported": [
    "English",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Telugu",
    "Marathi",
    "Tamil",
    "Urdu",
    "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": "2015",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "AI-driven 3D spinal imaging",
    "Non-invasive imaging without radiation exposure",
    "Real-time spinal alignment visualization",
    "Portable and easy-to-use design",
    "Enhanced patient engagement through clear visuals",
    "Improved diagnostic accuracy for better treatment planning",
    "Cost-effective solution with established reimbursable codes",
    "Continuous monitoring and assessment capabilities",
    "Broad applications including mass screening and treatment effectiveness",
    "Seamless integration into existing healthcare practices"
  ],
  "optional_modules": [
    "Advanced analytics",
    "Cloud storage integration",
    "Telehealth support",
    "Patient data management",
    "Automated reporting",
    "Mobile app integration",
    "Multi-user collaboration tools",
    "Customizable imaging protocols",
    "Patient education resources",
    "Remote diagnostics support"
  ],
  "integrations": [
    "Electronic Health Records (EHR)",
    "Picture Archiving and Communication System (PACS)",
    "Hospital Information System (HIS)",
    "Laboratory Information System (LIS)",
    "Clinical Decision Support Systems (CDSS)",
    "Telemedicine platforms",
    "Patient portals",
    "Billing systems",
    "Scheduling software",
    "Medical device interfaces"
  ],
  "data_standards": [
    "DICOM",
    "HL7",
    "FHIR",
    "SNOMED CT",
    "ICD-10",
    "LOINC",
    "CPT",
    "ICD-9",
    "NDC",
    "HCPCS"
  ],
  "api_available": "unknown",
  "system_requirements": "Web browser, iOS or Android device, Windows or macOS computer, Linux server",
  "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"
  ],
  "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"
  ],
  "security_features": [
    "Data encryption",
    "Role-based access control (RBAC)",
    "Single sign-on (SSO)",
    "Audit logs",
    "Two-factor authentication (2FA)",
    "Data loss prevention (DLP)",
    "Secure data transmission",
    "User authentication",
    "Session management",
    "Access controls"
  ],
  "privacy_features": [
    "Business Associate Agreement (BAA)",
    "Patient consent management",
    "Data anonymization",
    "Data minimization",
    "Data retention policies",
    "Access controls",
    "Audit trails",
    "Data masking",
    "User authentication",
    "Secure data storage"
  ],
  "data_residency": "US and EU data centers",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0145",
  "slug": "spineus-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/spineus-system.json"
  }
}