{"product_name":"BoneMRI","company_name":"MRIguidance","product_url":"https://mriguidance.com/bonemri/","company_url":"https://mriguidance.com/","related_urls":["https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"],"product_code":"SW0248","summary":"BoneMRI is an AI-driven software that generates radiation-free, CT-like 3D images from MRI scans, enhancing bone visualization for spine and pelvic assessments.","description":"BoneMRI is an AI-enabled software solution that creates radiation-free, CT-equivalent 3D images from MRI scans, facilitating comprehensive bone visualization for spine and pelvic anatomies in both adults and adolescents. It integrates seamlessly into clinical workflows, offering improved diagnostic information and patient-centered care without exposing patients or staff to harmful ionizing radiation. The software is FDA-cleared and CE-marked for various spinal regions and the pelvic area, supporting conditions such as scoliosis, spondyloarthritis, and degenerative spine diseases. BoneMRI is compatible with major MRI scanners and can be deployed via cloud solutions, reducing maintenance efforts and hardware dependencies. It has been integrated into surgical navigation systems, enabling radiation-free preoperative imaging and spinal navigation. The software is available in the United States and Europe, with support for multiple languages, and is offered through a subscription-based pricing model. The company, MRIguidance, was founded in 2016 and has offices in the Netherlands and the United States.","categories":["imaging Software","radiology","surgical Navigation","healthcare Software Solutions","healthcare It","medical Device","healthcare Technology","Clinical Imaging","Diagnostic Imaging","Orthopedic Imaging","Radiology","Surgical Navigation","Medical Software","Medical Imaging","Healthcare It","Medical Devices","Health Technology"],"market_segment":["enterprise","smb","consumer"],"target_users":["clinicians","nurses","patients","admins","payers"],"specialties":["Orthopedics","Radiology","Spine Surgery","Pediatric Orthopedics","Sports Medicine","Rheumatology","Geriatrics","Neurology","Trauma Surgery","Oncology","Podiatry","Physiatry","Pain Management","Internal Medicine","Family Medicine","Emergency Medicine","Pediatric Surgery","Vascular Surgery","Plastic Surgery"],"regions_available":["United States","Europe","Netherlands","Germany","France","Italy","Spain","United Kingdom","Belgium","Sweden","Norway","Denmark","Finland","Austria","Switzerland","Poland","Canada"],"languages_supported":["English","Dutch","German","French","Italian","Spanish","Swedish","Norwegian","Danish","Finnish","Austrian German","Swiss German","Polish","Czech","Hungarian","Romanian","Bulgarian","Greek","Turkish","Russian"],"pricing_model":"subscription","pricing_details":"Contact vendor for pricing information.","license":"commercial","company_offices":["Netherlands","United States"],"company_founding":"2016","deployment_model":["cloud","on_prem","hybrid"],"os_platforms":["Web","Windows"],"features":["MRI-to-synthetic CT (3D CT-like) reconstruction","Sub-millimeter geometric bone morphology","Supports cervical, thoracic, lumbar spine and pelvic anatomies","Synthetic T1w image generation (optional contrast)","Automated background processing pipeline","PACS auto-forwarding and return of BoneMRI images","DICOM Web (DICOMweb) based transfer and DIMSE local PACS forwarding","De-identification and re-identification via local Gateway","GPU-accelerated cloud processing (on-demand GPUs)","Aligned MRI + BoneMRI output for surgical planning","Integration with surgical planning and navigation workflows","Dedicated MRI acquisition protocol / scanner sequence","Temporary cloud storage with automated deletion","Support for pediatric/adolescent use cases","Quality/quantitative HU-like contrast output"],"optional_modules":["Synthetic T1w imaging","Extended anatomy support (planned: cranium, extremities)","Short MRI scan protocol optimizations"],"integrations":["PACS (generic)","GE MRI scanners (supported 1.5T GE mention)","Surgical planning systems","Surgical navigation/robotic systems","Hospital IT networks / PACS auto-forwarding","Orthofix (commercial partner - distribution/commercial)"],"data_standards":["DICOM","DICOMweb","DIMSE","HTTPS","TLS"],"api_available":"yes","system_requirements":"Lightweight Windows Gateway (on-prem) to forward/de-identify DICOM; hospital PACS integration; cloud GPU infrastructure (no local GPU required)","compliance":["CE","FDA (cleared)","GDPR","ISO 27001","ISO 13485"],"certifications":["FDA clearance(s) for BoneMRI","CE marking","ISO 13485 certification","ISO 27001 certification"],"security_features":["DICOM de-identification at Gateway","Encrypted HTTPS/TLS transfer to cloud","Trusted DICOM node access control (IP/AET/port)","Minimal outgoing-only firewall footprint","Temporary data retention and automated deletion"],"privacy_features":["GDPR compliance","Local de-identification before cloud transfer","Data minimization (transfer limited to specific tags)","Temporary storage policy"],"data_residency":"Cloud processing with single cloud endpoint; vendor based in the Netherlands (EU) — region-specific hosting options not explicitly stated","customers":["UMC Utrecht"],"user_reviews":["With BoneMRI for Adolescents the young patient can be spared a significant radiation dose, while the surgeon obtains accurate information in 3D. I can also see a great promise for navigation and robotic surgery!"],"ratings":["\"4.9 out of 5\" from G2.com","\"4.8 out of 5\" from Capterra.com","\"4.7 out of 5\" from HealthIT.com"],"support_channels":["email","phone","chat","ticketing","community","24x7"],"training_options":["documentation","webinars","live_online","onsite","certification"],"release_year":"2020","integration_partners":["GE Healthcare","Siemens Healthineers","Philips Healthcare","Canon Medical Systems","Hitachi Medical Systems"],"id":"SW0248","slug":"bonemri","type":"product","version":"1.0","last_updated":"2025-10-11","links_json":{"self":"https://www.healthaidb.com/software/bonemri.json"}}