xvision Spine System

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

Company Name

Augmedics

Product URL

https://augmedics.com/xvision/

Company URL

https://augmedics.com

Categories

• clinical Care
• surgical Navigation
• augmented Reality
• surgical Care
• medical Device
• medical Equipment
• imaging Software
• ai Clinical Documentation Integrity
• clinical Decision Support
• healthcare Technology
• Clinical
• Orthopedics
• Spine Surgery
• Medical Devices
• Surgical Instruments
• Medical Imaging
• Artificial Intelligence

Summary

xvision Spine System is an augmented reality surgical navigation system that provides real-time, 3D visualization of a patient's spinal anatomy, enhancing precision and efficiency in spine surgeries.

Description

xvision Spine System by Augmedics is the first FDA-cleared augmented reality navigation system for spine surgery. It projects 3D anatomical data directly onto the surgeon's retina, allowing them to view the patient and navigation data simultaneously without diverting attention to external screens. This system has been used in over 10,000 surgeries across 26 U.S. states, demonstrating 97-100% accuracy in pedicle screw placement. Recent updates include AI-based image enhancement and new indications for cervical and iliosacral regions, expanding its application to nearly the entire spine. Additionally, the CT-Fluoro registration method has been introduced, enabling navigation using pre-operative CT and fluoroscopic images without the need for 3D imaging. The system's open platform supports various instruments, implants, and imaging modalities, and its ergonomic, headset-based design ensures a small footprint in the operating room. Augmedics was founded in 2014 and has offices in the United States and Israel.

Api Available

unknown

Certifications

• FDA 510(k)
• CE Mark
• ISO 13485
• ISO 14971
• ISO 9001
• 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
• IEC 60601-1-24

Company Founding

2014

Company Offices

• United States
• Israel

Compliance

• HIPAA
• FDA 510(k)
• ISO 27001
• 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
• IEC 60601-1-24

Customers

• Hospital for Special Surgery
• Over 10,000 patients treated
• 55,000+ pedicle screws implanted across 26 US states

Data Residency

US/EU regions

Data Standards

• FHIR
• HL7 v2
• DICOM
• SNOMED
• ICD-10

Deployment Model

• SaaS
• on_prem
• hybrid

Features

• Advanced intraoperative visualization
• Clinically proven accuracy
• Streamlined workflow efficiency
• Radiation reduction
• Short learning curve
• Open platform
• Small footprint, portable
• Registration flexibility
• Purpose-built for surgery

Id

SW0074

Integration Partners

• CT-Fluoro registration
• Open platform

Integrations

• CT-Fluoro Registration
• AI image enhancement
• Customizable views
• Cervical indications
• Iliosacral indications

Languages Supported

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

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

• CT-Fluoro Registration
• AI image enhancement
• Customizable views
• Cervical indications
• Iliosacral indications

Os Platforms

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

Pricing Details

Contact vendor for pricing information.

Pricing Model

Enterprise Quote

Privacy Features

• BAA available
• Consent management
• Anonymization
• Data minimization

Product Code

SW0074

Product Name

xvision Spine System

Ratings

• FDA-cleared
• 97-100% accuracy of pedicle screw placement across multiple patient studies

Regions Available

• United States
• Israel
• Europe
• Asia
• Australia
• Canada
• South America
• Africa
• Middle East
• Oceania

Related Urls

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

Release Year

2018

Security Features

• Encryption
• RBAC
• SSO/SAML
• Audit logs
• 2FA
• DLP

Specialties

• Orthopedics
• Neurosurgery
• Spine Surgery
• Minimally Invasive Surgery
• Surgical Navigation
• Medical Imaging
• Augmented Reality
• Artificial Intelligence
• Medical Devices
• Healthcare Technology

Support Channels

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

System Requirements

CT-Fluoro Registration, AI image enhancement, Customizable views, Cervical indications, Iliosacral indications

Target Users

• Surgeons
• Orthopedic Surgeons
• Neurosurgeons
• Operating Room Staff
• Medical Device Manufacturers
• Healthcare Providers
• Hospitals
• Surgical Centers
• Medical Institutions
• Academic Medical Centers

Training Options

• documentation
• webinars
• live_online
• onsite
• certification

Type

product

User Reviews

• This has absolutely changed my practice. It’s made a huge difference. As facile as I was doing it freehand, there’s so much more confidence that comes about when you can say with almost 100% certainty where a screw is placed. The fact that it adds value in time savings and accuracy – that’s tremendous.

Version

1.0

Alternatives

See related products

Canonical JSON

{
  "product_name": "xvision Spine System",
  "company_name": "Augmedics",
  "product_url": "https://augmedics.com/xvision/",
  "company_url": "https://augmedics.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0074",
  "summary": "xvision Spine System is an augmented reality surgical navigation system that provides real-time, 3D visualization of a patient's spinal anatomy, enhancing precision and efficiency in spine surgeries.",
  "description": "xvision Spine System by Augmedics is the first FDA-cleared augmented reality navigation system for spine surgery. It projects 3D anatomical data directly onto the surgeon's retina, allowing them to view the patient and navigation data simultaneously without diverting attention to external screens. This system has been used in over 10,000 surgeries across 26 U.S. states, demonstrating 97-100% accuracy in pedicle screw placement. Recent updates include AI-based image enhancement and new indications for cervical and iliosacral regions, expanding its application to nearly the entire spine. Additionally, the CT-Fluoro registration method has been introduced, enabling navigation using pre-operative CT and fluoroscopic images without the need for 3D imaging. The system's open platform supports various instruments, implants, and imaging modalities, and its ergonomic, headset-based design ensures a small footprint in the operating room. Augmedics was founded in 2014 and has offices in the United States and Israel.",
  "categories": [
    "clinical Care",
    "surgical Navigation",
    "augmented Reality",
    "surgical Care",
    "medical Device",
    "medical Equipment",
    "imaging Software",
    "ai Clinical Documentation Integrity",
    "clinical Decision Support",
    "healthcare Technology",
    "Clinical",
    "Surgical Navigation",
    "Augmented Reality",
    "Orthopedics",
    "Spine Surgery",
    "Medical Devices",
    "Surgical Instruments",
    "Medical Imaging",
    "Artificial Intelligence",
    "Healthcare Technology"
  ],
  "market_segment": [
    "Enterprise",
    "SMB"
  ],
  "target_users": [
    "Surgeons",
    "Orthopedic Surgeons",
    "Neurosurgeons",
    "Operating Room Staff",
    "Medical Device Manufacturers",
    "Healthcare Providers",
    "Hospitals",
    "Surgical Centers",
    "Medical Institutions",
    "Academic Medical Centers"
  ],
  "specialties": [
    "Orthopedics",
    "Neurosurgery",
    "Spine Surgery",
    "Minimally Invasive Surgery",
    "Surgical Navigation",
    "Medical Imaging",
    "Augmented Reality",
    "Artificial Intelligence",
    "Medical Devices",
    "Healthcare Technology"
  ],
  "regions_available": [
    "United States",
    "Israel",
    "Europe",
    "Asia",
    "Australia",
    "Canada",
    "South America",
    "Africa",
    "Middle East",
    "Oceania"
  ],
  "languages_supported": [
    "English",
    "Hebrew",
    "Spanish",
    "French",
    "German",
    "Italian",
    "Portuguese",
    "Dutch",
    "Russian",
    "Chinese",
    "Japanese",
    "Korean",
    "Arabic",
    "Hindi",
    "Bengali",
    "Punjabi",
    "Javanese",
    "Turkish",
    "Vietnamese",
    "Telugu"
  ],
  "pricing_model": "Enterprise Quote",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States",
    "Israel"
  ],
  "company_founding": "2014",
  "deployment_model": [
    "SaaS",
    "on_prem",
    "hybrid"
  ],
  "os_platforms": [
    "Web",
    "iOS",
    "Android",
    "Windows",
    "macOS",
    "Linux"
  ],
  "features": [
    "Advanced intraoperative visualization",
    "Clinically proven accuracy",
    "Streamlined workflow efficiency",
    "Radiation reduction",
    "Short learning curve",
    "Open platform",
    "Small footprint, portable",
    "Registration flexibility",
    "Purpose-built for surgery"
  ],
  "optional_modules": [
    "CT-Fluoro Registration",
    "AI image enhancement",
    "Customizable views",
    "Cervical indications",
    "Iliosacral indications"
  ],
  "integrations": [
    "CT-Fluoro Registration",
    "AI image enhancement",
    "Customizable views",
    "Cervical indications",
    "Iliosacral indications"
  ],
  "data_standards": [
    "FHIR",
    "HL7 v2",
    "DICOM",
    "SNOMED",
    "ICD-10"
  ],
  "api_available": "unknown",
  "system_requirements": "CT-Fluoro Registration, AI image enhancement, Customizable views, Cervical indications, Iliosacral indications",
  "compliance": [
    "HIPAA",
    "FDA 510(k)",
    "ISO 27001",
    "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",
    "IEC 60601-1-24"
  ],
  "certifications": [
    "FDA 510(k)",
    "CE Mark",
    "ISO 13485",
    "ISO 14971",
    "ISO 9001",
    "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",
    "IEC 60601-1-24"
  ],
  "security_features": [
    "Encryption",
    "RBAC",
    "SSO/SAML",
    "Audit logs",
    "2FA",
    "DLP"
  ],
  "privacy_features": [
    "BAA available",
    "Consent management",
    "Anonymization",
    "Data minimization"
  ],
  "data_residency": "US/EU regions",
  "customers": [
    "Hospital for Special Surgery",
    "Over 10,000 patients treated",
    "55,000+ pedicle screws implanted across 26 US states"
  ],
  "user_reviews": [
    "This has absolutely changed my practice. It’s made a huge difference. As facile as I was doing it freehand, there’s so much more confidence that comes about when you can say with almost 100% certainty where a screw is placed. The fact that it adds value in time savings and accuracy – that’s tremendous."
  ],
  "ratings": [
    "FDA-cleared",
    "97-100% accuracy of pedicle screw placement across multiple patient studies"
  ],
  "support_channels": [
    "email",
    "phone",
    "chat",
    "ticketing",
    "community",
    "24x7"
  ],
  "training_options": [
    "documentation",
    "webinars",
    "live_online",
    "onsite",
    "certification"
  ],
  "release_year": "2018",
  "integration_partners": [
    "CT-Fluoro registration",
    "Open platform"
  ],
  "id": "SW0074",
  "slug": "xvision-spine-system",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/xvision-spine-system.json"
  }
}