FDA clears BoneXpert AI for automated bone age in pediatric radiographs

FDA clears Visiana’s BoneXpert AI for bone age assessment in ages 2–21. In a multicenter study, the software had a root mean square error of 0.55 years vs 0.76 for radiologists, and fewer errors >1.5 years (1.7% vs 6.4%). On-premise workflow keeps images local.

• BoneXpert provides annotated images showing bone contours and individual bone ages.
• The software withholds results when an image falls outside its validated scope.
• Already CE-marked and used clinically in Europe since 2009, supported by over 50 peer-reviewed studies.

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