FDA Has Cleared BoneXpert Software for Bone Age Assessment

The machine learning tool received 510(k) clearance to estimate bone age for patients aged 2 to 21.

Updated on Oct. 2, 2026 in Children’s Health

Isometric editorial illustration showing stylized, simplified geometric skeletal hand phalanges in a clean vertical alignment on a muted background. — The FDA has granted 510(k) clearance to Visiana for its BoneXpert software, a machine learning tool designed to automate pediatric bone age assessment. AI Illustration. Upload story photo >

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The FDA has granted 510(k) clearance to Visiana for its BoneXpert software, which uses machine learning to estimate bone age from hand radiographs. The tool is designed to integrate with PACS to provide automated analysis for patients between the ages of 2 and 21.

Why it matters

BoneXpert offers a standardized, automated approach to a common pediatric diagnostic process by utilizing the established Greulich-Pyle method. Its introduction provides clinicians with an alternative to manual radiologist assessment for determining skeletal maturity.

A multicenter study of 1,285 images across five U.S. sites showed BoneXpert had a 1.7% deviation rate of 1.5 years or more, significantly lower than the 6.4% rate observed for pediatric radiologists.

The players

Visiana

Visiana is a medical technology company that develops automated software solutions for pediatric skeletal assessment.

FDA

The Food and Drug Administration is the federal agency responsible for regulating medical devices in the United States.

The details

The software identifies bone age by analyzing hand radiographs using machine learning and provides clinicians with annotated images showing contours and specific bone ages directly in PACS. It has previously held the CE Mark and seen clinical use in Europe since 2009.

2009: BoneXpert began clinical use in Europe.
October 2026: Visiana releases BoneXpert in the U.S.

The Big Picture

The software automates the application of the Greulich-Pyle method, which has served as a benchmark for skeletal maturity assessments for decades.

Clinicians may soon use BoneXpert to provide faster, potentially more consistent bone age readings, which can help guide treatment for pediatric growth disorders. Parents should consult their pediatricians to understand if this new technology will be utilized in their child's diagnostic imaging process.

The takeaway

This clearance marks the entry of a long-standing European clinical tool into the American pediatric imaging landscape. The software could lead to more efficient radiology workflows for skeletal maturity evaluations across clinical settings.