FDA clears AI tool for pediatric bone age assessments
The U.S. Food and Drug Administration has cleared AI software designed to improve pediatric bone age assessments.
The 510(k) clearance covers Visiana’s BoneXpert, a machine learning software that determines bone age in patients ages 2 to 21 using the Greulich-Pyle method. The software is intended to support pediatric radiologists in evaluating children with growth and pubertal disorders.
Bone age assessments are commonly used to evaluate whether a child's skeletal development is consistent with their chronological age. Manual assessment is a known challenge and can vary between readers, potentially making longitudinal evaluation more difficult.
BoneXpert addresses this by analyzing radiographs of either hand and providing an annotated image showing the contours of the bones it evaluated and the individual bone ages assigned to them. The software also checks each radiograph and withholds a result when an image falls outside its validated scope, while the radiologist remains responsible for the final assessment and diagnostic decision.
The clearance was supported by a multicenter study conducted at five U.S. clinical sites. Images independently evaluated by four pediatric radiologists, with the average of the radiologists' manual readings used as the reference standard. These results were compared to BoneXpert’s outputs.
The software demonstrated a lower error rate than the individual radiologist comparison. Its root mean square error was 0.55 years, compared with 0.76 years for radiologists. It also had fewer results that differed from the reference by at least 1.5 years, at 1.7% compared to 6.4%.
The software runs on a computer within the hospital network, meaning patient radiographs do not leave the institution. Visiana believes the on-premise workflow can simplify security and HIPAA reviews during implementation.
“This clearance would not have been possible without the engagement of pediatric radiologists at the five U.S. sites, whose work documented BoneXpert’s accuracy at every site,” Hans Henrik Thodberg, CEO and founder of Visiana, said in a news release. “More broadly, it is the dedication of clinicians around the world, more than anything else, that has brought BoneXpert to where it is today," he added later.
BoneXpert has been used clinically in Europe since 2009 and is supported by more than 50 peer-reviewed studies. The software carries the CE mark and is used internationally.
Visiana plans to release BoneXpert in the U.S. in early October.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.