SpineAR SNAP (SyncAR Spine)

by Surgical Theater  · Based in United States → — Transforming Surgery with Experiential Reality
Neurosurgery Orthopedics

Contact for pricing
Regulatory Status Disclosed

Overview

SpineAR SNAP (SyncAR Spine) is an advanced software device developed by Surgical Theater, Inc., designed to enhance the precision and visualization of spinal implant surgeries. It transforms traditional 2D medical images, such as MRI and CT scans, into interactive 3D visualizations for comprehensive pre-operative planning and real-time intra-operative guidance. The platform supports planning on high-definition touch screens and in virtual reality (VR) environments, and provides intra-operative visualization through augmented reality (AR) headsets like Microsoft HoloLens2 and Magic Leap 1. SpineAR SNAP seamlessly integrates with existing operating room workflows and third-party navigation systems, including Medtronic StealthStation, to overlay navigation data directly onto the 3D anatomical models. This technology aims to improve surgical accuracy, patient outcomes, and surgeon confidence by providing an immersive and detailed understanding of patient-specific anatomy.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Transforms 2D medical images (CT, MRI) into interactive 3D visualizations
  • Supports pre-operative planning on screens and in virtual environments
  • Provides intra-operative guidance using AR headsets (HoloLens2, Magic Leap 1)
  • Integrates with third-party navigation systems (e.g., Medtronic StealthStation)
  • AI-driven vertebra segmentation for streamlined planning
  • Advanced Decompression Planning (ADP) to pre-map resections
  • Segmental Fusion to align preoperative models with intraoperative CT scans
  • Voxel-level drill tracking for real-time bone removal monitoring
  • 360u00b0 AR rendering overlay onto live images
  • Synchronized virtual probe for enhanced visual awareness

Use Cases

  • Pre-operative surgical planning and rehearsal for complex spine cases
  • Intra-operative guidance and visualization for spinal stereotaxic surgery
  • Precise pedicle screw placement in lumbar and thoracic regions
  • Patient engagement and education through immersive XR experiences
  • Enhancing precision and safety in minimally invasive spine procedures
  • Training and education for spine surgeons

What Physicians Need to Know

DICOM Support & Standards
SpineAR SNAP supports the transfer of imaging information from CT, MR, or X-ray 3D angiography (XA) medical scanners, transforming traditional 2D scans into interactive 3D models for surgical planning and visualization.
PACS Integration Method
The system is designed for seamless integration with existing surgical workflows and image guidance systems, specifically working with the Medtronic StealthStation navigation system. It extracts navigation data to present enhanced 3D images.
Reading Room Workflow Impact
SpineAR SNAP streamlines preoperative and intraoperative planning through AI-driven vertebra segmentation, reducing manual processing time. It enhances visualization with augmented reality (AR) headsets, allowing surgeons to maintain focus on the surgical field and gain real-time insight, aligning plans with execution.
AI Model Architecture (deep learning approach)
The platform is powered by AI algorithms, incorporating AI/ML-enabled vertebra segmentation to optimize surgical planning for screw placement and decompression. This AI function serves as a visualization tool for surgical planning, not a diagnostic one, and is validated through comprehensive testing and AI-model performance studies.
FDA Clearance Pathway (510k/De Novo)
SpineAR SNAP (SyncAR Spine) has received multiple FDA 510(k) clearances, including K213034 in September 2022 and K252054 for its next-generation platform in October 2025, classifying it as a Class II medical device.
Supported Modalities (CT/MRI/X-ray/US)
The system integrates and processes data from CT, MRI, and X-ray 3D angiography (XA) scans. It also provides intraoperative access to detailed MRI data, including nerves, vessels, and pathology.
Sensitivity & Specificity Data
Specific sensitivity and specificity data for SpineAR SNAP (SyncAR Spine) are not explicitly provided in the search results. However, the platform's latest FDA clearance was validated through comprehensive testing and AI-model performance studies.
RSNA/ACR Validation
No explicit mention of RSNA or ACR validation was found. However, Surgical Theater plans to premiere the updated SyncAR Spine platform at major events such as the Congress of Neurological Surgeons (CNS) Annual Meeting and the North American Spine Society (NASS) Annual Meeting.
Physician Tip

Leverage the AI-driven vertebra segmentation for streamlined preoperative planning, especially for screw placement and decompression, to significantly reduce manual processing time. Utilize the augmented reality (AR) headset (e.g., HoloLens2) for enhanced intraoperative visualization, allowing continuous focus on the surgical field while accessing critical 3D anatomical and navigation data. Integrate real-time MRI data into minimally invasive procedures to gain unprecedented clarity on nerves, vessels, and pathology, previously limited to open surgeries. Take advantage of features like Advanced Decompression Planning (ADP) and Segmental Fusion to maintain alignment between preoperative plans and intraoperative execution, even with patient positioning changes. Use voxel-level drill tracking for real-time monitoring of bone removal, enhancing precision and safety.

SpineAR SNAP (SyncAR Spine) is designed for seamless integration with existing surgical workflows and image guidance systems, particularly the Medtronic StealthStation navigation system. It functions as a software interface and image segmentation system, transferring imaging information from CT, MR, or X-ray 3D angiography (XA) scanners. The platform enhances current navigation capabilities rather than replacing them, providing richer intraoperative visualization by relying on positional information supplied by the connected navigation system to track surgical instruments.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentIntegrates with existing operating room workflows and third-party navigation systems (e.g., Medtronic StealthStation). Utilizes AR/VR headsets (Microsoft HoloLens2, Magic Leap 1) and high-definition touch screens.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

SpineAR SNAP (SyncAR Spine) received its latest 510(k) clearance (K252054) on September 29, 2025. It is indicated for pre-operative surgical planning and intra-operative visualization for spinal stereotaxic surgery, including pedicle screw placement in lumbar and thoracic regions.

Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics

What the Web Says

SpineAR SNAP (SyncAR Spine) is an FDA-cleared surgical extended reality (XR) platform that integrates AI-powered tools with existing surgical navigation systems, such as Medtronic StealthStation. It transforms 2D medical images into interactive 3D models, providing surgeons with enhanced visualization and guidance during spine surgery. Physicians have expressed strong positive opinions, highlighting its ability to bring real-time MRI data into the operating room and improve precision in minimally invasive procedures.

Overall: Positive

Strengths

  • Integrates seamlessly with existing surgical workflows and navigation systems.
  • Provides real-time MRI data in the operating room, enhancing visibility of nerves, vessels, and pathology.
  • Offers AI-assisted vertebra segmentation and advanced decompression planning for detailed pre-surgical mapping.
  • Enables voxel-level drill tracking for real-time monitoring of bone removal.
  • Transforms standard imaging into an interactive 3D surgical guide, improving precision in minimally invasive cases.
  • Designed as a comprehensive surgical XR platform, unlike systems relying solely on headset overlays.

Limitations

  • No specific cons were identified in the provided search results.
  • Limited independent reviews from platforms like G2, Capterra, or Reddit directly discussing user experience with SpineAR SNAP (SyncAR Spine) were found, beyond announcements of its use.

Based on reviews from: Medical Device Network, Newswire (PR Newswire), OrthoIndy, ODT Magazine, accessdata.fda.gov, Becker's Spine Review, MedicalExpo, Reddit

Last updated: 2026-07-20

Ratings & Reviews

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Clinical Value
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Press & Coverage

FDA
SpineAR SNAP (SyncAR Spine) - FDA 510(k) Premarket Notification K252054
This regulatory announcement details the FDA 510(k) clearance for SpineAR SNAP (SyncAR Spine) on September 29, 2025, classifying it as a Class II stereotaxic instrument for spinal surgery. It outlines the intended use for pre-operative planning and intra-operative guidance using AR headsets like HoloLens2.
2025-09
FDA
SpineAR SNAP (SyncAR Spine) - FDA 510(k) Premarket Notification K243623
This FDA 510(k) premarket notification, dated December 24, 2024, confirms the clearance of SpineAR SNAP (SyncAR Spine) as a Class II stereotaxic instrument. It specifies the device's use for spinal stereotaxic surgery and pedicle screw placement in the lumbar and thoracic regions with HoloLens2 and Magic Leap 1 AR headsets.
2024-12
FDA
Augmented Reality and Virtual Reality in Medical Devices
The FDA lists SpineAR SNAP (SyncAR Spine) by Surgical Theater, Inc. as an FDA-cleared augmented reality medical device for neurology, specifically for spinal stereotaxic surgery. This resource provides insights into the regulatory landscape and market for AR/VR in medical devices.
2026-06
Treeview Studio
Virtual Reality in Healthcare: AR/VR Statistics & Market Data (2026)
This report from June 2026 mentions SpineAR SNAP / SyncAR Spine by Surgical Theater, noting its multiple 510(k) clearances (Sep 2022, Dec 2024, Sep 2025) for AR spine surgical navigation built on patient-specific MRI and CT imaging.
2026-06
RadAI Slice (via Surgical Theater website)
Surgical Theater | Radiology AI Companies
Surgical Theater highlights SpineAR SNAP (SyncAR Spine) as a software device released on December 24, 2024, and September 29, 2025, with FDA regulatory clearance. It transforms 2D medical images into interactive 3D visualizations for pre-operative planning and intra-operative guidance using AR headsets.
2025-09
EIN Presswire
Worldwide Surgical Planning and Evaluation System Market 2026
A January 2026 press release mentions Surgical Theater and its development of SpineAR SNAP (SyncAR Spine) for preoperative and intraoperative 3D/AR surgical planning with AI/ML-enabled technology.
2026-01

Videos

Product demos, reviews, and walkthroughs for SpineAR SNAP (SyncAR Spine).

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Frequently Asked Questions

SpineAR SNAP (SyncAR Spine) integrates by transforming traditional 2D medical images into interactive 3D visualizations for both pre-operative planning and intra-operative guidance. It works with existing image guidance systems, such as Medtronic's StealthStation navigation, and utilizes AR headsets like HoloLens2 to project real-time surgical roadmaps and guidance cues directly into the surgeon's field of view, enhancing visualization without disrupting established routines.
SpineAR SNAP (SyncAR Spine) has received U.S. Food and Drug Administration (FDA) 510(k) clearance as a Class II medical device for spinal stereotaxic surgery. While the search results confirm FDA clearance, specific details regarding patient data privacy and security protocols were not explicitly provided.
A key limitation is that the virtual display should not be solely relied upon for absolute positional information and must always be used in conjunction with displayed 2D stereotaxic data. Like other AR technologies, there is a potential for technical glitches with either hardware or software.
Alternatives include traditional navigation systems, robotically assisted navigation platforms like MazorX and ExcelsiusGPS, and other augmented reality systems such as Augmedics xvision, Surgalign HOLO Portal, and Novarad VisAR. SpineAR SNAP differentiates itself by offering a comprehensive surgical XR platform that integrates MRI and CT data directly into the OR, aligning pre-op plans with intra-op execution, unlike some platforms that rely solely on headset overlays or proprietary navigation.
The search results do not explicitly detail the typical cost structure or pricing model for SpineAR SNAP (SyncAR Spine). Generally, AR surgical navigation systems are newer technologies, and their business models and financial performance for companies in this space are still evolving.
The AI in SpineAR SNAP (SyncAR Spine) primarily contributes to surgical accuracy by leveraging AI-driven vertebra segmentation, which streamlines pre-operative planning and reduces processing time. The latest FDA clearance for SyncAR Spine was validated through comprehensive testing and AI-model performance studies, demonstrating positional and angular accuracy comparable to predicate devices.
While specific training programs are not detailed in the search results, the system is designed to integrate seamlessly with existing workflows, enhancing navigation rather than replacing it. Surgical Theater, the developer, has extensive experience with over 50,000 clinical uses within its XR platforms, suggesting established support for their technologies.

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Suggest an Edit → | Last Verified: 2026-04-19 | First Added: 2026-04-19
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