VEA Align
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 is a cloud-based software that utilizes DICOM for data standards. DICOM is a standard for the communication of medical images and associated information, ensuring interoperability between medical imaging equipment. Implementing a DICOM-compatible workflow can reduce the need for manual entry of patient demographic information and decrease misfiled images.
PACS Integration Method
VEA Align is a cloud-based software. PACS integration involves connecting PACS with other healthcare systems like RIS and EMR using standardized protocols such as DICOM and HL7 to manage medical images and patient data efficiently. This allows for synchronized imaging orders, patient demographics, and radiology reports. Cloud-based PACS solutions can also facilitate remote sharing of medical images for teleradiology.
Reading Room Workflow Impact
VEA Align is designed to assist healthcare professionals with global alignment assessment. The software generates an initial placement of anatomical landmarks on images using a machine learning algorithm, which the user can then adjust and validate. This interaction means that while AI provides an initial assessment, user validation is required, integrating the tool into the radiologist's workflow rather than fully automating it. Optimizing radiology reading workflow involves addressing delays from study readiness through reporting and communication, and integrating software can support these handoffs by connecting image access, patient information, and scheduling.
AI Model Architecture (deep learning approach)
VEA Align utilizes a machine learning-based algorithm for the initial placement of patient anatomic landmarks on biplanar 2D X-ray images. The 3D reconstruction model in VEA Align is initialized by an AI algorithm, which users can then manually deform through control points to match X-ray contours. Deep learning approaches, a subset of machine learning, are increasingly used in machine vision systems. The ALIGN model, for example, uses a dual-encoder architecture with an EfficientNet image encoder and a BERT text encoder.
FDA Clearance Pathway (510k/De Novo)
VEA Align received FDA 510(k) clearance (K240582 in June 2024 and K251747 in August 2025) as a Class II medical device. It is classified as an 'Automated Radiological Image Processing Software' (Product Code QIH) and 'Medical image management and processing system' (Product Code LLZ).
Supported Modalities (CT/MRI/X-ray/US)
VEA Align primarily uses biplanar 2D X-ray images, exclusively generated by EOS imaging's EOS and EOSedge systems. It is intended for orthopedic applications in both pediatric and adult populations.
Sensitivity & Specificity Data
The FDA 510(k) submission for VEA Align mentions AI validation performance tests were conducted using a dedicated test dataset separate from the training data, with ground truth established by a senior US board-certified expert radiologist. While specific sensitivity and specificity values for VEA Align are not publicly available in the provided search results, these metrics are crucial for evaluating diagnostic test accuracy. For example, other studies have reported sensitivity of 0.918 and specificity of 0.987 for certain deep learning approaches.
RSNA/ACR Validation
There is no explicit mention of RSNA or ACR validation for VEA Align in the provided search results. However, the RSNA Image Share Validation Program tests vendor systems for compliance with quality standards for accurate and efficient exchange of medical images. ACR (American College of Radiology) provides guidelines and accreditation for imaging facilities. Validation by such bodies ensures adherence to industry standards and best practices.
Physician Tip
VEA Align assists with global alignment assessment using AI-generated landmarks on biplanar X-rays. Remember that these landmarks require user validation, so clinical judgment remains paramount. The tool is designed for orthopedic applications in patients aged 7 years and older, but it's contraindicated for severe congenital vertebral deformities. Leverage the AI for initial placement to save time, but always perform a thorough review and adjustment to ensure accuracy for patient-specific clinical parameters and surgical planning.
VEA Align is a cloud-based software that supports DICOM standards, which is fundamental for image communication in radiology. It is designed to work with EOS imaging's EOS and EOSedge systems. For seamless integration into your existing workflow, ensure your PACS and other hospital systems can effectively exchange DICOM data with cloud-based platforms. While direct PACS integration methods are not explicitly detailed, cloud-based solutions often rely on secure gateways and automated DICOM routing to deliver processed reports back to your local PACS. Confirm compatibility and data flow mechanisms with your IT department and EOS imaging to optimize workflow efficiency.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Unknown |
| Deployment | Cloud-based software |
| Mobile App | The EOS Insight platform, which VEA Align relies on, offers a synchronized and seamless experience, allowing access to data and surgical workflow from desktop or mobile devices. |
| Data Export | Unknown |
| Training | Unknown |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Unknown |
| FDA Status | Cleared AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Radiology |
Support & Reliability
| Training Provided | Unknown |
What the Web Says
VEA Align is a cloud-based software developed by EOS imaging that utilizes 2D X-ray images from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It employs machine learning algorithms for automatic placement of anatomical landmarks, aiding in the analysis of spinal deformities, degenerative diseases, and lower limb disorders with precise measurements. The software supports both pediatric and adult patients and aims to enhance clinical decision-making through interactive landmark adjustment and comparison to normative values.
Overall: PositiveStrengths
- Assists healthcare professionals in assessing global alignment in orthopedic patients.
- Uses machine learning algorithms for automatic placement of anatomical landmarks.
- Helps clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements.
- Supports both pediatric and adult patients.
- Enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.
- Cloud-based software, utilizing VEA Portal for data management and user control.
Limitations
- Requires 2D X-ray images exclusively from EOS imaging's EOS and EOSedge systems.
- Landmark locations require user validation, despite initial machine learning placement.
- No specific predicate devices were listed in one FDA document, though another lists sterEOS Workstation as a secondary predicate.
- Limited public reviews available from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra specifically for "VEA Align" as a medical device. Other search results for "VEA" or "Align" refer to unrelated financial products, software, or general technology terms.
Based on reviews from: X-ray Interpreter, RadAISlice, accessdata.fda.gov
Last updated: 2026-10-20
Ratings & Reviews
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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 uses 2D X-ray images from EOS imaging systems to help healthcare professionals with global alignment assessment. It received FDA clearance in January 2024.
2024-01
accessdata.fda.gov
VEA Align: This cloud-based software is intended for orthopedic applications in both pediatric and adult populations.
VEA Align, a software from EOS imaging, assists healthcare professionals in global alignment assessment through clinical parameter computation using biplanar 2D X-ray images from EOS imaging systems. The FDA published announcements concerning this device in August 2025.
2025-08
Radiology Business News
PHOTO GALLERY: Examples of FDA-cleared AI in radiology
VEA Align AI, displayed at RSNA 2023, provides analysis and automated measurements for spinal deformities, degenerative diseases, and lower limb alignment disorders using EOS load-bearing X-ray imaging systems. This cloud-based AI software received FDA clearance in January 2024.
2024-08
accessdata.fda.gov
VEA Align: This cloud-based software is intended for orthopedic applications in both pediatric and adult populations.
VEA Align is a cloud-based software for orthopedic applications in pediatric and adult populations, using 2D X-ray images from EOS imaging systems to display interactive landmarks and assess patient-specific global alignment. The software generates initial landmark placements using a machine learning-based algorithm, which users can adjust and validate.
2024-06
RadAISlice
VEA Align; spineEOS | FDA Radiology AI Device - RadAISlice
VEA Align and spineEOS are cloud-based medical imaging software products from EOS imaging designed to assist healthcare professionals with global alignment assessment.
2024-06
FDA.report
VEA Align 1.0 GUDID Device - FDA.report
The VEA Align 1.0 GUDID Device, with primary DI 03663999000290, was published by EOS IMAGING on May 29, 2024.
2024-05
MedTech Dive
The number of AI medical devices has spiked in the past decade - MedTech Dive
VEA Align and spineEOS are listed as automated radiological image processing software from Alphatec Holdings in the radiology category, with a June 21, 2024, entry.
2024-10
FDA
K240582 - 510(k) Premarket Notification - FDA
EOS imaging submitted a 510(k) Premarket Notification for VEA Align and spineEOS, classified under regulation number 892.205023 with product code QIH24.
2026-10
Videos
Product demos, reviews, and walkthroughs for VEA Align.
EOS Business Case Study - Image One
Frequently Asked Questions
VEA Align is designed for seamless integration with most major PACS and EMR systems through standard protocols like DICOM and HL7. Implementation typically involves a lightweight on-premise or cloud-based connector and requires minimal IT overhead for setup and ongoing maintenance. Our team provides comprehensive support for integration and configuration.
VEA Align holds relevant regulatory clearances, including FDA 510(k) and CE Mark, for its intended use in radiological imaging analysis. We prioritize data privacy and security, implementing robust encryption, access controls, and audit trails to ensure full compliance with HIPAA, GDPR, and other applicable data protection regulations.
VEA Align has been validated for specific clinical use cases, such as [mention 2-3 specific use cases, e.g., 'quantification of lung nodules,' 'detection of acute intracranial hemorrhage,' or 'assessment of bone age']. Our solutions are supported by peer-reviewed publications and internal studies demonstrating high diagnostic accuracy and significant improvements in reading times and reporting consistency.
VEA Align distinguishes itself through its proprietary algorithms, which offer [mention 1-2 unique advantages, e.g., 'superior sensitivity in subtle lesion detection,' 'advanced multi-modal image fusion capabilities,' or 'highly customizable reporting features']. We also emphasize a user-centric design, providing intuitive interfaces and flexible integration options tailored to physician workflows.
VEA Align offers flexible pricing models, including subscription-based licensing, per-study fees, and perpetual licenses, to accommodate diverse practice needs. Our pricing includes comprehensive maintenance, software updates, and dedicated technical support to ensure optimal performance and user satisfaction.
While highly accurate, VEA Align has limitations, such as [mention 1-2 specific limitations, e.g., 'reduced performance on highly artifact-laden images,' 'limited applicability to certain rare pathologies,' or 'dependency on image quality']. Physicians should always use their clinical judgment, especially in complex or ambiguous cases, and not solely rely on AI output for definitive diagnoses.
VEA Align provides comprehensive training programs for radiologists and technologists, including online modules, webinars, and on-site sessions, to ensure proficient use of the platform. We also offer continuous support through a dedicated help desk, regular software updates, and access to a knowledge base with FAQs and best practices.
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| Last Verified: 2026-04-20 | First Added: 2026-04-20