MicroMRI

 
MicroMRI has received 510(k) clearance from the Food and Drug Administration (FDA) to market its BoneVue™ software. Clearance of the BoneVue™ 510(k) application marks a milestone in the growth of the company as MicroMRI is now able to market its BoneVue™ image post-processing software in the US after completing the commercial release.
 
Dr. Michael Kleerekoper, Chief Medical Officer of MicroMRI said: “This is not only great news for the company but also for patients undergoing high-resolution MRI for visualization of bone micro-architecture. The concept of bone micro-architecture has been emerging for many years and its need was highlighted by the new definition for osteoporosis set by a Consensus Conference of NIH and FDA in 2000. High-resolution MRI is the first clinical routine method developed to visualize bone micro-architecture that does not rely on ionizing radiation and that uses standard clinical equipment.” Dr. Andreas Muehler, President & CEO of MicroMRI added: “MicroMRI can now begin the commercialization phase of our technology. Our product can be applied to MR images acquired on standard 1.5T and 3T scanners. The company is currently exploring distribution partnerships with major radiology companies.”
 
BoneVue™ is a software tool for 3D visualization of bone micro-architecture using MRI datasets with the possibility of manual or automated measurements of descriptive parameters regarding cortical and trabecular morphology. It is a workflow tool intended to assist a trained physician in the assessment of high–resolution MRI datasets of bone.