BoneMRI

MRIguidance
BoneMRI is a radiation-free software solution that generates a 3D CT-like (synthetic CT) image to visualize bone structures derived from an MRI scan. It is ideal to assist the diagnosis, monitoring and surgical planning and navigation of orthopaedic conditions. It is available for the Lumbar Spine, Cervical Spine and Pelvic Region.
Information source: Vendor
Last updated: Dec. 19, 2023

General Information

General
Product name BoneMRI
Company MRIguidance
Subspeciality MSK
Modality MR
Disease targeted Conditions involving the bony anatomy, such as radiculopathy, osteoarthritis, hip dysplasia, femoral acetabular impingement and spondyloarthritis, degenerative spine disease, spondylolisthesis, spondylosis and spinal fractures
Key-features Radiation-free bone visualisation from MRI data
Suggested use Visualize the latent bone structures in MRI images that may be used to assist the diagnosis, monitoring and treatment planning of orthopedic conditions in adult patients by imaging experts.

Technical Specifications

Data characteristics
Population Patients from 12 years and older suspected of having conditions involving the bony anatomy of the lumbar spine, cervical spine or pelvic region.
Input 3D MR protocol, gradient echo, multi echo, dual echo
Input format DICOM
Output Synthetic CT (sCT) in Hounsfield Units, 3D
Output format DICOM
Technology
Integration Integration in standard reading environment (PACS)
Deployment Locally on dedicated hardware, Cloud-based, Hybrid solution
Trigger for analysis Automatically, right after the image acquisition
Processing time > 10 minutes

Regulatory

Certification
CE
Certified, Class IIa , MDR
FDA 510(k) cleared , Class II
Intended Use Statements
Intended use (according to CE) BoneMRI is an image processing software that can be used for image enhancement in MRI images. It can be used to visualise the bone structures in MRI images with increased contrast with respect to the surrounding soft tissue, and may be used to assist the diagnosis, monitoring and treatment planning of orthopaedic conditions by imaging experts. It can be used to visualise T1w contrast. It is to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads; and the spine, which includes the bony anatomy of the cervical, thoracic, lumbar, and S1 vertebrae. BoneMRI can be used in patients 12 years and older.

Market

Market presence
On market since 04-2019
Distribution channels
Countries present (clinical, non-research use)
Paying clinical customers (institutes)
Research/test users (institutes)
Pricing
Pricing model Subscription
Based on Number of installations

Evidence

Evidence
Peer reviewed papers on performance

  • MRI-based synthetic CT of the lumbar spine: Geometric measurements for surgery planning in comparison with CT (read)

  • Magnetic resonance imaging-based synthetic computed tomography of the lumbar spine for surgical planning: a clinical proof-of-concept (read)

  • MRI-based synthetic CT shows equivalence to conventional CT for the morphological assessment of the hip joint (read)

  • MRI-based synthetic CT of the hip: can it be an alternative to conventional CT in the evaluation of osseous morphology? (read)

  • MRI-based Synthetic CT in the Detection of Structural Lesions in Patients with Suspected Sacroiliitis: Comparison with MRI (read)

  • Bone visualization of the cervical spine with deep learning-based synthetic CT compared to conventional CT: A single-center noninferiority study on image quality (read)

    Non-peer reviewed papers on performance
    Other relevant papers

    • Anatomical variation of the sacroiliac joints: an MRI study with synthetic CT images (read)

    • Common incidental findings on sacroiliac joint MRI: Added value of MRI-based synthetic CT (read)

    • MRI AI Use Case: Synthetic CT Images for Fracture Evaluation (read)