VEA Align
EOS imagingVEA Align is a cloud-based software developed by EOS imaging that uses 2D X-ray images acquired from EOS imaging systems to assist healthcare professionals in assessing global alignment in orthopedic patients. It applies machine learning algorithms to automatically place anatomical landmarks on images, helping clinicians analyze spinal deformities, degenerative diseases, and lower limb disorders with precise angle and length measurements. It supports both pediatric and adult patients and enhances clinical decision-making through interactive landmark adjustment and comparison to normative values.
Intended Use
Cloud-based software intended for orthopedic applications in pediatric and adult populations, using 2D X-ray images from EOS imaging systems to display interactive landmarks for patient-specific global alignment assessment and aid in analysis of spinal deformities, degenerative diseases, and lower limb alignment disorders.
Technology
VEA Align uses biplanar 2D X-ray images from EOS imaging's EOS and EOSedge systems. It applies a machine learning-based algorithm to generate an initial placement of anatomical landmarks on frontal and lateral images, which users can adjust. The software is cloud-hosted and utilizes VEA Portal for data management and user control.
Performance
Nonclinical performance testing including design input review, unit and integration testing, usability testing, and validation of reproducibility and accuracy was conducted. A dataset of 555 patients from EOS and EOSedge systems was used to compare landmark detection accuracy to predicate device sterEOS Workstation (K172346), meeting acceptance criteria.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/29/2023
6 months - 2
FDA Approval
1/5/2024
Other devices from EOS imaging
- VEA Align; spineEOS2024 • 510K
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.