Yes, there are a number of peer reviewed papers available on the Clinical Evidence page that detail the benefits of using BoneMRI.
BoneMRI is MRI-based, and therefore sensitive to MRI artefacts, such as signal voids near metal. These signal voids cannot be reconstructed into CT-like data and will be represented differently compared to CT.
No. Due to the reconstruction time needed to generate a BoneMR image, the BoneMRI product cannot be used in acute situations.
BoneMRI is available for the Cervical Spine, Lumbar Spine, and Pelvic Region.
To assess if these anatomies are supported by your MRI scanner, please check the table below.
BoneMRI is available for Philips, Siemens, and GE scanners.
To assess the anatomical coverage for BoneMRI reconstructions using these scanners, please check the table below.
BoneMRI can be used for adult patients and adolescents 12 years+ (in the EU) suspected of having conditions involving the bony anatomy.
BoneMRI is a cloud based service. Connection from your hospital to the cloud environment is established by a dedicated Gateway module where patient’s direct identifiers are removed before it is sent to the cloud endpoint.
The Gateway module will be delivered as a windows installer file.
The BoneMRI reconstruction job is automatically triggered, immediately after the acquired source data is received on PACS. BoneMRI reconstruction times differ, depending on the size of the field of view of the acquisition, but typically are in between 5 and 90 minutes.
The BoneMRI algorithm is fixed at the time of deployment. This means that the BoneMRI algorithm does not change after final validation or after installation. The installed BoneMRI algorithm does not learn from new input data acquired at your clinical site.
The BoneMRI algorithm is trained based on deep learning technology (see answer on AI method). The BoneMRI algorithm is extensively validated based on quantitative claims and qualitative reviews by clinical experts. Furthermore, BoneMRI is validated in clinical studies, which can be found on the Clinical Evidence page.
The BoneMRI algorithm is trained and validated on real patient data. The data is acquired with clinical studies and is a reliable representation of data that can be expected in clinical practice.
The training and validation data include data from different hospitals, countries, MRI vendors, MRI field strengths, anatomies and patient populations.
The BoneMRI algorithm is extensively validated for application to different patient populations, including osteoarthritis, hip dysplasia, femoral acetabular impingement, spondyloarthritis, degenerative spine disease, spondylolisthesis, radiculopathy, spondylosis and spinal fractures. An overview of clinical studies can be found on the Clinical Evidence page.
The BoneMRI algorithm is based on deep learning. Deep learning is a type of machine learning that uses artificial neural networks to process input data and provide a specific output. By providing the deep learning network with many (real-life) examples it can learn and improve until a desired performance is reached.
Read BoneMRI Explained: How Deep Learning Is the Backbone of Our Product to learn more.
MRI is considered safe, since no ionising radiation is used. Your doctor and MRI technologist will make sure residual risks related to MRI scanning are reduced to a minimum.
BoneMRI is indicated for use in adult patients only.
Contact your local radiologist and discuss your options/availability.
BoneMRI is currently available for the EU, UK & US markets.
No, BoneMRI is an MRI image with a CT-like contrast for the bony regions. However, the image is made on the basis of an MRI scan. This means images from the bones as well as the soft tissue can be obtained in a single examination, without the need of going into two different machines.
An MRI examination consists of several images being made. A BoneMRI acquisition is one of such images, and can be part of a regular MRI examination. Besides an extra image to be made, there will be no difference to the examination.
Yes. BoneMRI is compliant with all relevant data protection regulations. Further details on how we process data is discussed within Data Processing Agreements that are signed with each customer.
MRIguidance has a high focus on information security. We show that by ensuring our product development complies with international standards on information security, and by ensuring that our whole organisation takes information security in consideration. We have implemented an Information Security Management System, for which we have obtained an ISO 27001 certificate. This certificate is available upon request.
Yes. BoneMRI is CE certified as a class IIa medical device under the EU Medical Device Regulations.
In addition, it is also cleared for use on the US market via FDA 510(k) clearance.
MRIguidance holds an ISO 13485 certificate for their Quality Management System and an ISO 27001 certificate for their Information Security Management System. These certificates are available upon request.
Protected Health Information is removed before the data is sent to the cloud application, with the exception of a number of indirect identifiers that are required for processing of the data. Further details and rationale are provided in the Instructions for Use.