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.
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.