xvision Spine

by Augmedics  · Based in United States → — Augmented Reality Surgical Navigation for Spine Procedures
Neurosurgery Orthopedics
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Regulatory Status Disclosed

Overview

The Augmedics xvision Spine System® is a pioneering augmented reality (AR) guidance system designed to revolutionize spine surgery. It allows surgeons to visualize a patient’s 3D anatomy, including bones, muscles, tendons, ligaments, and spinal discs, as if they have “x-ray vision” directly within their field of view during procedures. This eliminates the need to look away at a distant screen, enhancing surgeon focus, control, and visualization. The system accurately navigates instruments and implants, aiming to improve precision, workflow efficiency, and patient outcomes. It is built on an open platform, allowing compatibility with various instruments, implants, and imaging choices. The xvision Spine System has consistently demonstrated high accuracy in pedicle screw placement across multiple patient studies.

Augmedics has continued to innovate, introducing the next-generation X2™ AR headset, which offers an all-new form factor for maximized comfort, balance, and wearability in the operating room. The X2 features a detachable, surgical-grade headlight and novel lens tilt for ergonomic support, along with enhanced technical and optical specifications, including a 100% increase in field of view and image resolution.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Advanced augmented reality visualization (x-ray vision)
  • Real-time 3D anatomical overlay
  • Accurate instrument and implant navigation
  • Enhanced workflow efficiency
  • Reduced radiation exposure (relative to fluoroscopic guidance)
  • Short learning curve with intuitive interface
  • Open platform for instrument and implant choice
  • Small footprint and portable headset-based system
  • Flexible registration (pre-op CT or intraoperative 3D imaging)
  • Purpose-built for surgery (X2 headset features)

Use Cases

  • Pedicle screw placement
  • Posterior lumbar decompression
  • Slipped vertebrae (spondylolisthesis) correction
  • Spinal fusion procedures
  • Thoracic and lumbar posterior fusions
  • Complex deformity and revision surgeries

What Physicians Need to Know

Surgical Planning Capabilities
Utilizes preoperative CT scans to generate a 3D model of the patient's spinal anatomy, enabling surgeons to virtually plot procedures and plan virtual trajectories for instruments and implants.
Intraoperative Guidance
Provides 'x-ray vision' by superimposing real-time 3D spinal anatomy and navigation data directly onto the surgeon's retina via a transparent near-eye-display headset. This allows surgeons to accurately navigate instruments and implants while looking directly at the patient, eliminating the need to divert attention to a remote screen.
3D Reconstruction Quality
Generates a perfectly replicated 3D model of the patient's specific spine from CT scan data, projecting both 3D spinal anatomy and 2D CT images directly into the surgeon's field of view.
Robotic Surgery Integration
The xvision Spine System is an augmented reality tool that can be integrated with robotic image guidance systems, such as Globus Medical ExcelsiusGPS, to provide enhanced anatomical views and complement robotic precision.
Surgical Navigation Accuracy
Demonstrated 98.9% screw placement accuracy in cadaver studies and clinically proven accuracy of 99.1%. Studies report pedicle screw placement accuracy rates ranging from 93% to 100%, significantly reducing the risk of neurological and vascular complications.
Pre-Operative Assessment
Leverages preoperative CT scans to create the foundational 3D anatomical model, enabling virtual plotting of procedures based on the patient's unique anatomy before surgery.
Operating Room Workflow Integration
Designed for intuitive integration into the surgical workflow with a small footprint and compatibility with existing instrumentation. It streamlines procedures by eliminating the need for surgeons to look away from the patient, potentially reducing operative time and surgeon fatigue.
Physician Tip

Leverage the direct, real-time 3D anatomical overlay to maintain continuous focus on the patient and surgical field, enhancing precision for instrument and implant placement, especially in complex or minimally invasive cases. Utilize the virtual trajectory guidance for efficient and accurate procedural planning. Be mindful of the potential for reduced radiation exposure for both the surgical team and the patient compared to traditional fluoroscopy-based methods. The system's intuitive design and open platform facilitate a short learning curve and seamless integration into existing surgical workflows.

The xvision Spine System is compatible with traditional navigation systems and current surgical instrumentation. It integrates preoperative CT scans for its 3D anatomical reconstruction and can be used in conjunction with robotic image guidance systems like Globus Medical ExcelsiusGPS. Recent acquisition by VB Spine suggests future integration opportunities within their visualization portfolio and SpineHawk platform.

Details

Category Surgical AI
Pricing Contact for pricing — System cost reported around $179,000 (2020); contact vendor for current pricing.
DeploymentHardware (headset-based system) with integrated software
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The xvision Spine System is FDA 510(k) cleared. Augmedics also received FDA 510(k) clearance for its next-generation X2™ AR headset in November 2025, and for a new CT-Fluoro registration method in November 2024. Software updates include cybersecurity and HIPAA enhancements.
Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

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Press & Coverage

Augmedics
Augmedics completes 10,000th augmented reality spine surgery with xvision Spine System
Augmedics announced it has completed its 10,000th augmented reality spine surgery using the xvision Spine System, marking a new record for AR navigation in spine surgery. This milestone coincides with the commercial launch of its CT-Fluoro registration method, expanding navigation access for surgeons.
2025-04
Augmedics
Augmedics announces FDA clearance of next-generation AR headset, X2u2122
Augmedics received FDA 510(k) clearance for X2u2122, its next-generation AR headset for the xvision Spine System, featuring an improved design for comfort, a 100% increase in field of view, and enhanced image resolution. The X2 headset is purpose-built for surgery and will be debuted at the North American Spine Society (NASS) Annual Meeting.
2025-11
VB Spine
VB Spine to Acquire Exclusive Rights to xvision Spine System from Augmedics
VB Spine announced its agreement to acquire exclusive rights to the xvision Spine System from Augmedics, integrating augmented reality navigation into its visualization portfolio. This acquisition aims to enhance precision in various spine procedures and is subject to regulatory approvals.
2026-02
Cureus (PMC)
Augmented Reality in Spine Surgery: A Narrative Review of Clinical Accuracy, Workflow Efficiency, and Barriers to Adoption
This narrative review discusses the clinical accuracy, workflow efficiency, and barriers to adoption of augmented reality in spine surgery, highlighting Augmedics' xVision as a solution that provides real-time overlays of patient anatomy and screw trajectories. The review notes that AR can produce equivalent or superior results to conventional systems, particularly in minimally invasive settings.
2025-06
Augmedics
Augmedics announces FDA clearance, completion of first surgery for new CT-Fluoro registration
Augmedics received FDA 510(k) clearance for its new CT-Fluoro registration method for the xvision Spine System, allowing surgeons to navigate using a preoperative CT scan and standard 2D C-arm fluoroscopic images. This method eliminates the need for 3D intraoperative imaging, expanding access to navigation.
2024-11
Augmedics
Augmedics marks record-setting 5,000 spine patients treated in another first for augmented reality surgery
Augmedics announced that its xvision Spine System has been used to treat a record-setting 5,000 patients, further solidifying its leadership in AR surgery. This achievement followed a year of significant developments for the company, including the launch of its first AI application and an $82.5 million Series D financing.
2023-12
FDA
FDA 510(k) Clearance for xvision Spine System
The FDA granted 510(k) clearance to Augmedics' xvision Spine System, an image-guided navigation system intended to aid in precisely locating anatomical structures during open or percutaneous spine procedures. The system uses a headset and optical tracking technology to display instrument locations relative to patient scans.
2019-12
PMC
Augmented Reality-Assisted Spine Surgery: An Early Experience Demonstrating Safety and Accuracy with 218 Screws
This prospective observational study evaluated the safety and accuracy of AR-navigated thoracolumbar fusion surgery using the Augmedics xvision-Spine system. The study reported an overall Gertzbein-Robbins accuracy of 97.1% across 218 AR-guided screws with no intra- or early postoperative complications.
2022-03

Videos

Product demos, reviews, and walkthroughs for xvision Spine.

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Frequently Asked Questions

The xvision Spine System integrates into surgical workflows by providing augmented reality visualization directly in the surgeon's field of view, eliminating the need to look away at external monitors. It is designed for workflow efficiency, with an intuitive, 'video game-like' interface that facilitates a short learning curve for surgeons and staff.
The xvision Spine System is FDA 510(k) cleared, indicated for precisely locating anatomical structures during open or percutaneous spine procedures. As an FDA-cleared medical device handling patient data, it is designed to adhere to stringent data privacy regulations, including HIPAA, through secure and encrypted data handling protocols.
xvision Spine differentiates itself by offering 'x-ray vision' through an AR headset, superimposing 3D anatomical and navigation data directly onto the patient, which allows surgeons to maintain focus on the surgical field without distraction. This contrasts with traditional navigation systems that often require surgeons to shift their gaze to a separate screen. While other AR/XR systems exist, xvision is noted for its pioneering role and high clinical penetration.
Initial reports from 2019 suggested the xvision Spine System could cost between $20,000 to $50,000, significantly less than conventional navigation systems, though a 2020 report cited a cost of approximately $179,000. Its cost-effectiveness stems from potential reductions in operative time, radiation exposure for staff and patients, and improved surgical precision, which can lead to better patient outcomes and efficiencies for the practice.
While xvision Spine has demonstrated high accuracy, consistently achieving 97-100% pedicle screw placement accuracy in multiple studies, the virtual display should be used in conjunction with stereotaxic information and not solely for absolute positional data. Initial clinical experience was limited, but more extensive use has shown its utility across various spinal procedures, including complex cases. Broader adoption may still be limited by cost and the need for more large-scale, multicenter trials.
The xvision Spine System processes patient imaging data to create 3D models for surgical navigation. While specific technical details on data storage and breach prevention are not extensively detailed in public summaries, as an FDA-cleared medical device, it is expected to employ secure, encrypted communication and data handling protocols to protect patient information and comply with relevant healthcare data security standards.
Multiple studies and clinical use have demonstrated the efficacy and safety of the xvision Spine System, with reported pedicle screw placement accuracy rates ranging from 97% to 100%. Clinical evidence suggests it improves surgical accuracy, reduces radiation exposure for both patients and surgical teams, and enhances workflow efficiency by minimizing the need for surgeons to look away from the patient. Over 13,000 patients have been treated with the system.

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Suggest an Edit → | Last Verified: 2026-04-21 | First Added: 2026-04-21

Investors who backed xvision Spine

Funded through the company that built this tool.

New Harbor Venture Partners
VC T3
Spring Lake, United States
$5M-$25M
New Harbor Venture Partners is a US venture firm with a website and LinkedIn presence consistent with a small or boutique investor…
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