VEA Align

by EOS imaging  · Based in France →Connecting Imaging to Care
Neurosurgery Orthopedics Radiology

Regulatory Status Disclosed

Overview

VEA Align by EOS imaging is a cloud-based, machine learning-driven software application designed to assist healthcare professionals with global skeletal alignment assessments. The tool is intended for orthopedic surgeons, radiologists, and clinical staff in both pediatric and adult care settings, specifically for patients aged seven years and older.

The software integrates into the clinical workflow by processing biplanar 2D X-ray images generated exclusively by EOS and EOSedge imaging systems. It functions through the following capabilities:

  • Automated Landmark Placement: Uses a machine learning-based algorithm to generate an initial placement of anatomical landmarks on frontal and lateral X-ray images.
  • Interactive Adjustments: Allows clinicians to manually adjust and validate landmark locations to match the patient’s unique anatomy.
  • Parameter Computation: Automatically calculates and updates clinical alignment parameters, such as angles and lengths, as landmark adjustments are made.
  • Surgical Planning Integration: Supports the export of 3D datasets to spineEOS software to facilitate preoperative surgical planning.

VEA Align serves as a diagnostic aid for analyzing spinal deformities, degenerative diseases, and lower limb alignment disorders. It is accessed via the cloud-based EOS Insight platform.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-based automated radiological image processing
  • Global alignment assessment through clinical parameters computation
  • Analysis of spinal deformities and degenerative diseases
  • Analysis of lower limb alignment disorders and deformities
  • Precise angle and length measurements
  • Uses biplanar 2D X-ray images from EOS imaging systems (EOS and EOSedge)
  • Cloud-based software accessible via web browser
  • Interactive landmarks with user validation
  • Preoperative planning of spine surgeries (for VEA Align; spineEOS)
  • Leverages low radiation dose imaging from underlying EOS systems

Use Cases

  • Diagnosis and treatment planning for spinal conditions (e.g., scoliosis, kyphosis, spinal deformities)
  • Diagnosis and treatment planning for lower limb alignment disorders and deformities (e.g., hip dysplasia, limb length discrepancy)
  • Preoperative planning for spine surgeries
  • Monitoring disease progression in conditions requiring frequent imaging
  • Assessment of global skeletal alignment and balance
  • Pediatric orthopedic applications

What Physicians Need to Know

DICOM Support & Standards
VEA Align processes biplanar 2D X-ray images exclusively generated by EOS imaging's EOS and EOSedge systems. Required DICOM fields for input images include Referring Physician, Date of Birth, Patient Name, and Patient ID. Image transmissions to the cloud-based platform are managed by VEA Portal or EOS Insight, utilizing HTTPS for secure data transfer.
PACS Integration Method
VEA Align operates as a cloud-based software, accessible via the EOS Insight platform. Integration involves the EOS imaging systems transmitting 2D X-ray images to the cloud (VEA Portal/EOS Insight) for processing, rather than direct PACS integration as a DICOM node within a local network. The platform handles user access control and data acquisition.
Reading Room Workflow Impact
VEA Align assists healthcare professionals, primarily surgeons and clinical staff, with global alignment assessment. It overlays interactive landmarks on frontal and lateral 2D X-ray images, with initial placement driven by machine learning algorithms that users can adjust. This tool aids in the analysis of spinal deformities, degenerative diseases, and lower limb alignment disorders, aiming to streamline assessment workflows.
AI Model Architecture (deep learning approach)
VEA Align employs machine learning-based algorithms to automate radiological image processing and analysis. The initial sizing and placement of interactive anatomical landmarks are derived from a 3D reconstruction model built from the 2D biplanar X-ray images. While 'deep learning' is not explicitly stated, the use of 'machine learning-based algorithms' and 'AI-driven alignment assessment' indicates an advanced computational approach.
Processing Speed (per study)
Crucial alignment information, including level-identification, calculated measurements, and color-coded patient benchmarking to normative values, is available within minutes of every full-body EOSedge exam. Optimal performance requires a stable, high-speed internet connection.
FDA Clearance Pathway (510k/De Novo)
VEA Align has received multiple 510(k) clearances from the FDA. Key clearances include K231917 (January 2024) and K240582 (June 2024) for VEA Align and spineEOS, and K251747 (August 2025). It is classified as a Class II medical device under product code QIH (Automated Radiological Image Processing Software).
Supported Modalities (CT/MRI/X-ray/US)
VEA Align exclusively supports biplanar 2D X-ray images acquired from EOS imaging's EOS and EOSedge systems. It does not support CT, MRI, or Ultrasound modalities.
Physician Tip

VEA Align is a valuable cloud-based tool for global alignment assessment, offering AI-driven initial landmark placement on biplanar 2D X-ray images from EOS imaging systems. Remember that while the AI provides assistance, your clinical judgment and experience are paramount for accurate diagnosis and treatment planning. Ensure patients are in a standing, weight-bearing position for optimal image acquisition, as seated positions may yield inaccurate results. Training by EOS imaging or Alphatec Spine is required for proper use. Maintain a stable, high-speed internet connection and an updated web browser with 100% zoom for the best user experience. Be aware of contraindications, such as severe congenital vertebral deformities. While not for mobile device *use*, alignment assessments can be *viewed* on mobile devices via the EOS Insight platform.

VEA Align is tightly integrated within the EOS imaging ecosystem, functioning as a cloud-based application accessible through the EOS Insight platform. It exclusively processes images from EOS and EOSedge systems, with data acquisition and user access managed securely via VEA Portal or EOS Insight. The platform is hosted on a HIPAA-compliant datacenter, ensuring data security through HTTPS. Furthermore, VEA Align can export 3D datasets for use in spineEOS, facilitating a seamless workflow from alignment assessment to surgical planning.

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Unknown
DeploymentCloud-based web application
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

VEA Align; spineEOS (K251747) is an FDA-cleared Class II medical device (Product Code QIH) for automated radiological image processing software, indicated for assisting healthcare professionals with global alignment assessment and preoperative planning of spine surgeries.

Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics, Radiology

What the Web Says

VEA Align is a cloud-based software developed by EOS imaging that assists healthcare professionals in assessing global alignment in orthopedic patients using 2D X-ray images from EOS imaging systems. It applies machine learning algorithms to automatically place anatomical landmarks, aiding in the analysis of spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. The software supports both pediatric and adult patients (aged 7 years and older) and allows for interactive landmark adjustment and comparison to normative values.

Overall: Positive

Strengths

  • Low-dose radiation compared to traditional X-rays and CT scans, especially beneficial for pediatric patients requiring frequent imaging.
  • Provides detailed 2D and 3D images for precise measurement of bones, joints, and alignment.
  • Machine learning algorithms for automatic placement of anatomical landmarks, enhancing efficiency.
  • Cloud-based software with secure data management and user control via VEA Portal.
  • Enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.
  • High reproducibility in measuring various parameters of alignment.

Limitations

  • Requires patients to be able to stand in a small cabin space, making it unsuitable for non-ambulatory or very large patients.
  • Image quality may not be as crisp and clear as conventional X-rays for detecting subtle issues like undisplaced fractures.
  • Contraindicated for cases with severe congenital vertebral deformities (e.g., hemivertebrae, spina bifida) and supernumerary/missing vertebrae.
  • Clinical judgment and experience are required to properly use the software; it should not be used as the sole basis for clinical decisions.
  • Requires specific screen resolution for full display of the interface and proper cache management for optimal functioning.
  • Some measurements, like femoral and tibial torsion, may show inconsistencies and lower agreement with CT 3D models, requiring careful interpretation.

Based on reviews from: X-ray Interpreter, ATEC Spine, Hardian Health, HSS, PMC, Innolitics

Last updated: 2026-07-20

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Press & Coverage

X-ray Interpreter
VEA Align | FDA Radiology AI Device - X-ray Interpreter
VEA Align is a cloud-based software by EOS imaging that received FDA approval on January 5, 2024. It uses machine learning to assist healthcare professionals in assessing global alignment in orthopedic patients from 2D X-ray images.
2024-01
X-ray Interpreter
VEA Align; spineEOS | FDA Radiology AI Device - X-ray Interpreter
VEA Align; spineEOS, an AI-based software by EOS imaging, was approved by the FDA on August 15, 2025. It is designed to automatically process radiological images of the spine to aid in diagnosing and treatment planning for spinal conditions.
2025-08
accessdata.fda.gov
510(k) Premarket Notification - FDA (K240582)
This FDA 510(k) summary from June 25, 2024, details VEA Align as a software for global alignment assessment using biplanar 2D X-ray images from EOS imaging systems, suitable for pediatric and adult orthopedic applications.
2024-06
accessdata.fda.gov
510(k) Premarket Notification - FDA (K251747)
An FDA 510(k) premarket notification from August 15, 2025, describes VEA Align as a cloud-based software for orthopedic applications in pediatric and adult populations, utilizing 2D X-ray images for patient-specific global alignment assessment.
2025-08
Hardian Health
VEA Align; spineEOS - HaRi - Hardian Health
Hardian Health provides an overview of VEA Align; spineEOS, highlighting its FDA authorization (K251747) on August 15, 2025, as an automated radiological image processing software for orthopedic applications and preoperative spine surgery planning.
2025-08
ResearchGate
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - ResearchGate
A December 2025 research paper discusses VEA Align (K231917) and VEA Align; spineEOS (K240582) as machine learning-enabled orthopedic and spinal alignment planning devices authorized by the FDA in 2024.
2025-12
PMC
Machine Learning-Enabled Medical Devices Authorized by the US Food and Drug Administration in 2024: Regulatory Characteristics, Predicate Lineage, and Transparency Reporting - PMC
This December 2025 article from PMC highlights VEA Align; spineEOS (K240582) as an FDA-authorized machine learning-enabled medical device for spinal alignment planning and analysis in 2024.
2025-12
MedTech Dive
The number of AI medical devices has spiked in the past decade - MedTech Dive
MedTech Dive reported on October 9, 2024, that VEA Align; spineEOS, developed by Alphatec Holdings (which acquired EOS imaging), was among the AI-enabled medical devices authorized by the FDA, contributing to the significant increase in such devices over the last decade.
2024-10

Videos

Product demos, reviews, and walkthroughs for VEA Align.

View all on YouTube

Frequently Asked Questions

VEA Align is a cloud-based AI software that processes biplanar 2D X-ray images from EOS imaging systems to assist healthcare professionals with global alignment assessment. It automatically places anatomical landmarks, which users can then adjust and validate to compute clinical parameters for diagnosing and planning treatment for spinal conditions.
VEA Align is a Class II medical device, cleared by the FDA (K231917, K251747) as automated radiological image processing software. It is hosted on a datacenter certified for hosting Patient Health Information (PHI) and is HIPAA compliant, ensuring data confidentiality and integrity through HTTPS protocol for communication.
VEA Align is contraindicated for cases with severe congenital vertebral deformities (e.g., hemivertebrae, spina bifida) and supernumerary/missing vertebrae. Importantly, it should not be used as the sole basis for making clinical decisions related to patient diagnosis, treatment, or care.
VEA Align exclusively uses biplanar 2D X-ray images generated by EOS imaging's EOS (K152788) and EOSedge (K202394) systems. Its software compatibility is therefore limited to these specific imaging systems.
VEA Align is hosted on a cloud infrastructure certified for Patient Health Information (PHI) and is HIPAA compliant. It employs HTTPS protocol for encrypted end-to-end communication and requires unique user accounts with automatic logout to maintain data confidentiality and integrity.
Individual hands-on training is required and provided by qualified employees from Alphatec Spine or EOS imaging for each end-user. This ensures that surgeons and clinical staff, who are the intended users, possess the necessary skills and credentials for treating orthopedic patients with the software.
The publicly available search results do not provide specific pricing details for VEA Align by EOS imaging. Typically, pricing for specialized medical device software like VEA Align is obtained directly from the vendor, EOS imaging or Alphatec Spine, through a consultation or request.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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