BoneMRI

by MRIguidance B.V.  · Based in Netherlands →Pioneering radiation-free bone imaging with AI-enabled software.
Neurosurgery Orthopedics Radiology

Contact for pricing
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

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing Usage-based, per analysis; contact for details
DeploymentCloud-based and on-premise (server application). Data sent to cloud is de-identified.
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

BoneMRI is an image processing software cleared by the FDA (K233030, K230197, K202404) for image enhancement in MRI images to visualize bone structures with enhanced contrast in the spine (cervical, thoracic, lumbar, S1) and pelvic region for patients 12 years and older. It is not intended to replace CT images or for diagnosis/monitoring of (primary or metastatic) tumors.

Integrations
EHR Not specified
Specialties Neurosurgery, Orthopedics, Radiology

What the Web Says

BoneMRI, developed by MRIguidance, is an image processing software that generates 3D CT-like images of bone structures from MRI scans. It aims to provide comprehensive visualization of both bone and soft tissue in a single, radiation-free examination, which is particularly beneficial for diagnostics and surgical planning in the spine and pelvic region. The technology has received FDA clearance for use in patients aged 12 and older and is available in the EU, UK, and US markets.

Overall: Positive

Strengths

  • Radiation-free imaging, reducing patient exposure to harmful X-rays, especially beneficial for younger patients and those requiring multiple scans.
  • Provides optimal visualization of both soft and bony structures in a single scan, offering a 'one-stop-shop' imaging solution.
  • High accuracy in detecting and characterizing structural lesions, outperforming conventional MRI in some cases.
  • Supports surgical planning and navigation with comparable accuracy to CT scans, allowing for radiation-free pre-planning.
  • Seamless integration into existing radiological workflows and compatibility with common MRI scanner brands (Philips, Siemens, GE).
  • Potential to reduce diagnosis time and healthcare costs by eliminating the need for separate CT scans.

Limitations

  • BoneMRI images are not intended to replace CT images in general.
  • Some Reddit discussions about full-body MRIs (not specific to BoneMRI) raise concerns about lower resolution compared to targeted scans and the potential for incidentalomas leading to unnecessary anxiety and further testing.
  • The cost of MRIs can be a barrier, and insurance coverage for advanced MRI techniques like BoneMRI may be an issue.
  • G2 and Capterra, platforms where reviews might be sought, have received criticism regarding the reliability and authenticity of their reviews, with some users reporting issues with review publishing and incentivized reviews.

Based on reviews from: AuntMinnie, MRIguidance (official website and YouTube channel), Neurosurgical Focus (via MRIguidance), Radiology (via MRIguidance), Physician Ai Tools, Reddit, accessdata.fda.gov, PubMed, G2, Capterra, Trustpilot

Last updated: 2026-07-18

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Press & Coverage

MRIguidance
BoneMRI Release Introduces New Stitching Functionality and Expands Scanner Support
MRIguidance released an update to BoneMRI in February 2026, introducing new stitching functionality for total spine views and expanding compatibility with various MRI scanners and IT environments. This update aims to improve clinical confidence and reduce interpretation time for radiologists, MR technologists, IT teams, and surgeons.
2026-02
AuntMinnie
MRIguidance secures FDA clearance for BoneMRI
MRIguidance received U.S. FDA clearance for its BoneMRI image processing software, which generates 3D CT-like images from MRI scans to enhance bone structure visualization for diagnosis and treatment planning. The initial clearance covers the pelvic region, with plans to extend to the spine.
2026-06
MRIguidance
Leadership Transition at MRIguidance: Roel Kellenaers Steps Aside, Guido Zijl Appointed CEO
Guido Zijl has been appointed CEO of MRIguidance, succeeding Roel Kellenaers, with a focus on accelerating the adoption of BoneMRI in the US and Europe and expanding the company's platform capabilities. Zijl brings over 20 years of leadership experience in the medical device industry.
2026-02
MRIguidance
BoneMRI Secures Trademark Registration in US, UK, and EU
BoneMRI has achieved trademark registration in the European Union, United Kingdom, and United States, a significant step in strengthening its global brand and expanding its presence in the medical imaging industry. This protects the brand's identity and reinforces its unique value proposition.
2025-10
MRIguidance
BoneMRI in Practice: An Overview of Clinical Results and Innovative Applications
This article provides an overview of clinical results and innovative applications of BoneMRI, highlighting its potential in fracture detection, diagnosis of pediatric spondylolysis, and surgical planning and navigation, with a significant reduction in radiation burden compared to CT. Studies show BoneMRI's accuracy and value in various clinical scenarios.
2025-07
MRIguidance
BoneMRI receives Medicare billing code
BoneMRI has received a new Medicare billing code, G0566, establishing a clear reimbursement pathway for the technology in the outpatient hospital setting. This expands access for US patients and providers to radiation-free bone imaging.
2025-05
Gillette Children's
Gillette Offers Radiation-Free Imaging with BoneMRI
Gillette Children's has implemented BoneMRI, a technology that provides radiation-free, CT-like images from MRI scans, eliminating the need for traditional CT scans in pediatric patients. This is a significant advancement for surgical planning and diagnosis, especially for conditions like scoliosis.
2024-10
MRIguidance
BoneMRI for the Total Spine
BoneMRI received CE marking and FDA clearance for visualization of the total spine (cervical, thoracic, and lumbar) and pelvic region, providing a comprehensive overview of spinal deformities and pathologies for adults and adolescents. This enables radiation-free treatment planning and navigation.
2024-03

Videos

Product demos, reviews, and walkthroughs for BoneMRI.

View all on YouTube

Frequently Asked Questions

The AI in BoneMRI generates 3D CT-like images from MRI scans, providing detailed visualization of bone structures without radiation exposure. This can lead to improved diagnostic information, potentially reducing the need for additional CT scans and streamlining workflows by offering both bone and soft tissue information from a single exam.
BoneMRI is CE certified as a Class IIa medical device under EU Medical Device Regulations and has received FDA 510(k) clearance for various anatomies, including the spine and pelvic region. It is also compliant with data protection regulations such as HIPAA, EU GDPR, and UK DPA, with further details typically outlined in Data Processing Agreements.
BoneMRI's AI provides radiation-free, CT-like images from MRI scans, offering sub-millimeter quantitative equivalence to CT for bone structures. This differentiates it by offering a comprehensive view of both bone and soft tissue in a single exam, potentially reducing radiation exposure for patients compared to CT.
While specific pricing models for BoneMRI are not detailed in the search results, AI solutions in healthcare often involve subscription fees or per-study charges. The projected ROI for AI in radiology can be significant, driven by factors like increased efficiency, reduced costs from fewer exams, and improved patient outcomes, with some studies showing high returns when valuing radiologists' time and downstream care.
BoneMRI is MRI-based and thus sensitive to MRI artifacts, such as signal voids near metal implants, which cannot be reconstructed into CT-like data. While BoneMRI's algorithm is trained and validated on diverse patient data from various hospitals, countries, and MRI vendors to avoid biases, AI algorithms in general can exhibit biases if training datasets do not adequately represent diverse patient populations, potentially leading to varied performance across different demographic groups or complex pathologies.
BoneMRI ensures patient data privacy by de-identifying Protected Health Information (PHI) before it is sent to the cloud application, with only indirect identifiers necessary for processing being transferred. The system uses a dedicated Gateway module on hospital premises for de-identification and secure data exchange via DICOM Web standard over HTTPS, adhering to regulations like HIPAA and GDPR.
BoneMRI integrates seamlessly into radiology workflows as a cloud-based service, utilizing a Gateway module installed on hospital premises to connect with existing PACS. It supports standard protocols like DICOM for image transfer and can be acquired via platforms like the Siemens Healthineers Digital Marketplace, ensuring compatibility with major MRI scanners and standard reading environments.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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