FDA Cleared AI Software for Pediatric Bone Age

New machine learning software helps clinicians estimate bone age for patients aged 2 to 21 using hand radiographs.

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

Isometric editorial illustration of a sculptural, white polymer model of a child's hand skeleton, representing medical diagnostic software analysis. — The FDA has granted 510(k) clearance to BoneXpert, an AI-based software designed to standardize and automate skeletal maturity assessment in pediatric patients. AI Illustration. Upload story photo >

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The FDA has granted 510(k) clearance to the BoneXpert software, which uses machine learning to assess skeletal maturity in children and young adults. This diagnostic tool will become available in the U.S. in early October 2026.

Why it matters

Bone age assessments are critical for monitoring pediatric growth and developmental disorders, and this software offers a standardized, automated approach to imaging analysis. The technology is designed to assist radiologists by providing faster, more consistent interpretations of hand radiographs.

A multicenter study of 1,285 hand radiographs from five U.S. sites found the software had a root mean square error of 0.55 years, compared to 0.76 years for pediatric radiologists. Additionally, the software showed a 1.7% deviation rate of 1.5 years or more, versus 6.4% for human clinicians.

The players

Visiana

A developer of AI-based medical imaging software specializing in pediatric skeletal assessment tools.

FDA

The federal agency responsible for evaluating the safety and efficacy of medical devices before they reach the U.S. market.

The details

BoneXpert works by analyzing hand radiographs and identifying individual bone contours to estimate skeletal age based on the established Greulich-Pyle method. The software integrates directly with Picture Archiving and Communication Systems (PACS) to overlay these findings onto medical images. By automating the identification of specific anatomical markers, it provides a consistent, objective measurement that assists radiologists in assessing growth development.

BoneXpert has been in clinical use in Europe since 2009.
Visiana will release the software for U.S. use in October 2026.

Health Landscape

This software represents a shift toward automated diagnostics in pediatric radiology, building upon the long-standing use of the Greulich-Pyle bone age atlas. It marks an evolution from traditional manual interpretation toward AI-assisted workflows that prioritize consistency and speed.

If your child requires an assessment of skeletal maturity, this software may now be available as part of their imaging process in participating clinics. You can ask your pediatrician or pediatric endocrinologist if digital bone age analysis is used to help interpret your child's growth progress.

The takeaway

AI-assisted diagnostics are increasingly standard in pediatric care to improve the accuracy of growth monitoring. If you are concerned about your child's development, discuss the role of diagnostic imaging and standardized assessment tools during your next visit with your child's physician.