FDA clearance for Lumbar Spine BoneMRI

Healthcare professionals and patients in the USA can now benefit from this radiation-free imaging technique. 

Utrecht, November 16, 2022 – The US Food & Drug Administration (FDA) announced the 510(k) clearance of MRIguidance’s BoneMRI for Lumbar Spine. This clearance expands the availability of BoneMRI in the US market where BoneMRI for Pelvic Region was already cleared last year.

BoneMRI is a software solution integrated in the clinical workflow that generates a 3D CT-like image to accurately visualise 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 adult patients with degenerative orthopaedic conditions.

“I am proud that our team managed to receive FDA clearance for the second application —Lumbar Spine— within a year. This is a huge achievement and an important milestone for our company and a remarkable benefit for our US customers and their patients!”, commented Rik Jacobs, CEO of MRIguidance.

BoneMRI is an MDR CE Class IIa medical device certified for the pelvic region, cervical and lumbar spine for clinical use in Europe and has FDA 510(k) clearance in the pelvic region and lumbar spine for marketing in the USA.

 

What are the characteristics of BoneMRI?
  • Geometrically accurate bone morphology
  • Quantitative HU contrast
  • Radiation-free bone imaging
How does BoneMRI work?
  • Seamless integration: BoneMRI is automatically reconstructed and forwarded to PACS.
  • Dedicated ​​protocol: 4 minute MRI sequence to extract the right data from the scanner.

BoneMRI for

Cervical Spine

BoneMRI for

Lumbar Spine

BoneMRI for

Pelvic Region

About MRIguidance

MRIguidance is a medical imaging software company that develops and markets BoneMRI, the world’s first imaging technique that visualizes both bone and soft-tissue from one imaging exam without the use of harmful radiation.

 

Want to learn more about BoneMRI? See this video

Utrecht, February 2026 – MRIguidance has released a new update to BoneMRI, making the solution easier to use across the hospital workflow while expanding compatibility with scanners, systems, and IT environments.

A key feature of the release is new stitching functionality, which allows clinicians to generate combined anatomical regions of e.g. the cervical, thoracic and lumbar spine, into a single, continuous image, providing total spine views. This enables assessment of pathology across multiple spinal regions without switching between image series, which might improve clinical confidence by visualizing anatomical relationships in one comprehensive view, and reduce interpretation time by eliminating manual cross-referencing between sub-regions.

The update also introduces extended compatibility across imaging platforms and infrastructure. BoneMRI now supports pelvic region imaging across the full range of GE, Siemens, and Philips MRI scanners at both 1.5T and 3T. In addition, the software expands support for Enhanced DICOM processing and is now compatible with Windows Server 2025 OS via the MRIguidance Gateway.

These improvements enhance interoperability with MRI scanners and DICOM inputs, simplify coordination with hospital IT departments, and broaden anatomical and vendor coverage to support smoother clinical adoption.

The release also includes additional support and security enhancements.

The latest BoneMRI update benefits radiologists, MR technologists, IT teams, and surgeons, further strengthening BoneMRI’s role in efficient, radiation-free bone imaging across clinical workflows.

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