Healthcare specialists and patients in the US can now benefit from MRIguidance’s software product BoneMRI for the pelvic region.

Utrecht, January 12th, 2022 – MRIguidance announces that the US Food & Drug Administration (FDA) has cleared their medical imaging software product BoneMRI for the pelvic region, the first radiation-free bone and soft tissue imaging method for marketing in the US.

BoneMRI is a software solution integrated in the clinical workflow that generates a 3D CT-like image to accurately visualize bone structures. It is derived from an MRI scan and creates new possibilities for bone imaging without exposing the patient to harmful radiation. It is aimed for diagnosis and treatment planning.

“This approval is a very important milestone for MRIguidance. This FDA clearance expands our previous certifications beyond European Certification (CE) for BoneMRI in the pelvic region, the cervical and lumbar spine. Now healthcare specialists and patients in the US can also benefit from our software solution in the pelvic region. We aim to extend the FDA clearance to the spine later this year”, said co-founder and CTO, Marijn van Stralen.

BoneMRI for the pelvic region is intended for patients suffering from orthopedic conditions. It is an image processing software that can be used for image enhancement in MRI images that integrates seamlessly with radiological imaging workflows. It can be used to visualize the bone structures in MRI images with increased specificity and enhanced contrast with respect to the surrounding soft tissue. BoneMRI accurately reconstructs the 3D bone morphology and voxelwise estimates the radiodensity contrast. It is intended to be used in the pelvic region, which includes the bony anatomy of the sacrum, hip bones and femoral heads.

In patients suspected of spine diseases, BoneMRI for the cervical spine visualizes 3D information on potential bone involvement, relating to disc displacement or degeneration, new bone formation, degenerative disease and foraminal narrowing in patients suspected of a herniated disc or foraminal stenosis.

BoneMRI for the lumbar spine is intended to visualize the latent bone structures for the assessment of the degenerative spine. In addition, it may assist in surgical planning and navigation as it offers 3D visualisation of the osseous structures for accurate geometric assessment.

About MRIguidance

MRIguidance is a UMCU spin-off founded in 2016 by MR physicist Peter Seevinck and image scientist Marijn van Stralen, who partnered with med-tech entrepreneur Roel Raatgever. The team at MRIguidance works in close collaboration with hospitals to develop and clinically validate BoneMRI (its proprietary technology) to benefit value-based healthcare and deliver safe patient care. MRIguidance markets MDR Class II a certified BoneMRI for the pelvic region, lumbar and cervical spine in the EU, and from now, also for the pelvic region in the US.

About MRIguidance

MRIguidance is a UMCU spin-off founded in 2016 by MR physicist Peter Seevinck and image scientist Marijn van Stralen, who partnered with med-tech entrepreneur Roel Raatgever. Based in Utrecht, the team at MRIguidance works in close collaboration with hospitals to develop and clinically validate its proprietary technology to benefit value-based healthcare and deliver safe patient care. MRIguidance markets MDR Class II a certified BoneMRI for the pelvic region, lumbar and cervical spine in the EU, and from now, also for the pelvic region in the US.