BoneMRI
Regulatory Status Disclosed
Overview
BoneMRI is an innovative AI-enabled software developed by MRIguidance B.V. that generates radiation-free, CT-like 3D images of bone structures from standard MRI scans. This technology allows for the visualization of both bone and soft tissue in a single examination, eliminating the need for ionizing radiation associated with traditional CT scans. It is designed for use in the spine (cervical, thoracic, lumbar, and S1 vertebrae) and pelvic region for patients 12 years and older. BoneMRI aims to enhance diagnostics, improve surgical planning and navigation, and streamline clinical workflows by providing accurate, high-resolution bone morphology and tissue radiodensity information. The software integrates seamlessly into existing radiological imaging workflows, automatically reconstructing and forwarding images to PACS. It supports major MRI scanners from GE, Siemens, and Philips at both 1.5T and 3T.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Radiation-free CT-like images from MRI
- 3D bone morphology reconstruction with quantitative equivalence to CT
- Visualize bone and soft tissue in one exam
- CT DICOM compatibility for seamless workflow integration
- Orthogonal and oblique reformats for enhanced visualization
- Faster image acquisition, reducing scan time to less than four minutes
- Secure, PHI-free processing in the cloud
- Stitching functionality for total spine views
- Compatibility with major MRI scanners (GE, Siemens, Philips, 1.5T & 3T)
- Accurate reconstruction of tissue radiodensity and radiodensity contrast
Use Cases
- Diagnostics of orthopedic conditions (e.g., fractures, spondylolysis, sacroiliitis)
- Surgical planning and navigation for spine and pelvis
- Monitoring of orthopedic conditions
- Treatment planning for various musculoskeletal pathologies
- Reducing radiation exposure for patients and clinical staff
- Streamlining clinical workflow and increasing efficiency in imaging departments
What Physicians Need to Know
DICOM Support & Standards
BoneMRI operates as a DICOM node within the hospital network, receiving and sending DICOM images. It supports DICOM Web standard for secure data exchange over HTTPS. BoneMRI can generate an axial reformat packaged as a CT DICOM for integration into CT-based workflows.
PACS Integration Method
BoneMRI integrates seamlessly with PACS. MRI images are automatically forwarded from PACS to a BoneMRI Gateway module, which de-identifies the data before sending it to the BoneMRI Cloud application. After processing, the BoneMRI image is re-identified and returned to PACS.
Reading Room Workflow Impact
BoneMRI aims for seamless workflow integration. Both the original MRI and the BoneMRI images are available on the reading workstation, allowing radiologists to visualize soft tissues and bony structures simultaneously without needing a separate CT examination.
AI Model Architecture (deep learning approach)
BoneMRI utilizes a deep learning approach for image synthesis, transforming MRI images into CT-like images. The model learns a mapping from MRI to CT data, with training under strict constraints to ensure output accuracy, matching predicted BoneMRI output to actual CT scans voxel-to-voxel.
Processing Speed (per study)
BoneMRI reconstruction times typically range between 5 and 15 minutes, depending on the field of view.
FDA Clearance Pathway (510k/De Novo)
BoneMRI has received FDA 510(k) clearance for the pelvic region, lumbar spine, and for adolescents (12 years and older) for both pelvic and spine anatomies. It also has FDA clearance for the total spine (cervical, thoracic, lumbar) and pelvic region.
Supported Modalities (CT/MRI/X-ray/US)
BoneMRI generates CT-like images from MRI scans. It is designed to work with MRI data acquired using a dedicated BoneMRI scan protocol.
Sensitivity & Specificity Data
In a prospective evaluation of 44 cervical spine fractures, BoneMRI demonstrated 97.3% sensitivity in detecting fractures and showed near-perfect intermodal agreement with CT in classifying injuries. Studies have shown BoneMRI to be non-inferior to CT for overall bone image quality in the cervical spine and equivalent to CT for assessing hip morphology in pediatric patients.
RSNA/ACR Validation
While direct RSNA/ACR validation is not explicitly mentioned, BoneMRI has undergone extensive clinical validation studies, with results published in journals like the European Journal of Radiology.
Physician Tip
BoneMRI provides radiation-free, CT-like images from MRI scans, which is particularly beneficial for pediatric patients and those requiring repeated imaging. It offers detailed 3D bone visualization alongside soft tissue information from a single MRI exam, streamlining diagnosis and surgical planning. Consider its use for assessing spinal and pelvic conditions where CT radiation is a concern, and for surgical navigation workflows.
BoneMRI integrates with hospital PACS systems via a Gateway module and supports DICOM standards for image transfer. It is available through the Siemens Healthineers Digital Marketplace and can be integrated into navigation workflows, such as Brainlab.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing | Unknown |
| Deployment | On-premise (seamless workflow integration, images automatically reconstructed and forwarded to PACS) |
| Compliance | |
| BAA Available | Unknown |
| HIPAA Compliant | Unknown |
| FDA Status | Cleared AI-estimated |
| GDPR | Yes AI-estimated |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Radiology |
What the Web Says
BoneMRI, developed by MRIguidance, is an AI-enabled software that generates radiation-free, CT-like 3D images of bone structures from MRI scans, primarily for the spine and pelvic regions. It is designed to assist physicians in diagnosis, monitoring, and treatment planning for orthopedic conditions, offering a radiation-free alternative to traditional CT scans. The software integrates into existing radiological workflows and has undergone clinical validation, demonstrating noninferiority to CT for certain applications and improved diagnostic performance over conventional MRI in specific cases.
Overall: PositiveStrengths
- Radiation-free imaging, which is particularly beneficial for young patients and those requiring frequent imaging.
- Provides CT-like images from MRI scans, offering detailed visualization of bone structures.
- Improved diagnostic performance for certain conditions compared to conventional MRI.
- Seamless integration into existing radiology workflows.
- Potential for use in surgical planning and navigation, potentially reducing the need for X-ray-based imaging during surgery.
- Validated through clinical studies and qualitative reviews by clinical experts.
Limitations
- The BoneMRI algorithm is currently designed to work only for specific anatomical areas: the cervical spine and the pelvic region.
- As an MRI-based technology, it is sensitive to MRI artifacts, such as signal voids near metal implants, which cannot be reconstructed into CT-like data.
- Requires a specific acquisition protocol for suitable source data.
- The direct diagnosis is ultimately decided by the physician, as the application visualizes bone structures.
Based on reviews from: mriguidance.com, ovid.com, scribd.com, auntminnie.com
Last updated: 2026-10-31
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Press & Coverage
mriguidance.com
MRIguidance and Acuña y Fombona Sign Distribution Agreement
MRIguidance has partnered with Acuña y Fombona to distribute BoneMRI to healthcare providers in Spain and Portugal, expanding its reach in Europe. This agreement aims to make radiation-free bone imaging more accessible in these regions.
2026-10
mriguidance.com
BoneMRI Release Introduces New Stitching Functionality and Expands Scanner Support
A new BoneMRI update introduces stitching functionality, allowing clinicians to combine images of different spinal regions into a single, continuous view. The update also expands compatibility with various MRI scanners and IT environments, enhancing workflow integration.
2026-02
mriguidance.com
Leadership Transition at MRIguidance: Roel Kellenaers Steps Aside, Guido Zijl Appointed CEO
Guido Zijl, with over 20 years of experience in the medical device industry, has been appointed as the new CEO of MRIguidance, succeeding Roel Kellenaers. Zijl's focus will be on scaling BoneMRI and expanding its access in the US and Europe.
2026-02
mriguidance.com
BoneMRI Secures Trademark Registration in US, UK, and EU
BoneMRI has achieved trademark registration in the European Union, United Kingdom, and United States, strengthening its global brand identity and protecting its logo. This milestone supports the company's expansion in the medical imaging industry.
2025-10
mriguidance.com
BoneMRI receives Medicare billing code
BoneMRI has been assigned a Medicare billing code (HCPCS G0566), establishing a clear reimbursement pathway for the technology in the outpatient hospital setting. This is a significant step towards expanding access to radiation-free bone imaging for US patients and providers.
2025-05
mriguidance.com
Brainlab Spine & Trauma Navigation System now supports BoneMRI
The Brainlab Spine & Trauma Navigation System now supports BoneMRI, marking a significant advancement towards radiation-free spine navigation and optimized surgical workflows. This integration aims to enhance precision and safety in spine surgery.
2025-04
mriguidance.com
BoneMRI introduces new features for faster scanning and enhanced imaging
The latest version of BoneMRI includes new features such as CT DICOM compatibility, orthogonal and oblique reformats, and faster image acquisition, reducing scan times to under four minutes. These enhancements aim to improve workflow, provide more diagnostic information, and enable radiation-free CT-based surgical workflows.
2025-02
mriguidance.com
BoneMRI now available in Siemens Healthineers Digital Marketplace
BoneMRI has launched on the Siemens Healthineers Digital Marketplace, making its radiation-free bone imaging software accessible to a wider range of healthcare professionals in the US and Europe. This collaboration aims to seamlessly integrate BoneMRI into existing clinical workflows.
2025-01
Frequently Asked Questions
BoneMRI is an AI-enabled, cloud-based software that generates CT-like images of bone from MRI scans, providing both bone and soft tissue visualization in a single, radiation-free examination. Unlike traditional CT, it avoids ionizing radiation, and it offers enhanced bone detail compared to conventional MRI, which typically excels in soft tissue imaging.
BoneMRI is intended to assist in the diagnosis, monitoring, and treatment planning of orthopedic conditions, particularly in the cervical spine, lumbar spine, and pelvic regions. It offers benefits such as radiation-free bone imaging, improved patient-centered care by potentially reducing the need for multiple exams, and seamless integration into existing clinical workflows by automatically forwarding reconstructed images to PACS.
BoneMRI is compliant with data protection regulations such as HIPAA, EU GDPR, and UK DPA. It is CE certified as a Class IIa medical device under EU Medical Device Regulations and has FDA 510(k) clearance for use in the US market.
BoneMRI is not intended for use in acute situations due to the reconstruction time required to generate the images. Additionally, as it is MRI-based, it is sensitive to MRI artifacts, such as signal voids near metal implants, which cannot be reconstructed into CT-like data. The algorithm is designed for specific anatomical areas (cervical spine, thoracic spine, lumbar spine, and pelvic region) and should not be used elsewhere.
BoneMRI integrates seamlessly into the clinical workflow by operating as a DICOM node within the hospital network. It receives 3D classic single-frame DICOM MRI data, automatically reconstructs the BoneMRI images, and then forwards the resulting DICOM images back to the hospital's PACS for visualization with any qualified DICOM-compatible medical image viewing software.
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| Last Verified: 2026-04-18 | First Added: 2026-04-18