Musculoskeletal (MSK)Devices & AI clearances

FDA clears Mriguidance BoneMRI for MRI-based bone visualization

U.S. FDA2w ago

FDA clears Mriguidance's BoneMRI via 510(k) pathway, enabling MRI-based bone imaging without ionizing radiation.

  • Cleared under product code QIH (MRI system) with Radiology committee review.
  • Software intended to generate bone-like images from standard MRI data, potentially reducing radiation exposure.
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