Visiana has received U.S. Food and Drug Administration (FDA) 510(k) clearance for BoneXpert, the company's machine-learning software for estimating bone age from hand radiographs.
The software, which assesses bone age from patients age 2 to 21 using the Greulich-Pyle method, sends an annotated image to the patient's study in PACS showing the contours and individual bone ages of each bone it analyzed.
In a multicenter study of 1,285 images from five U.S. sites, BoneXpert had a lower root mean square error than a pediatric radiologist when compared with a reference standard (0.55 vs. 0.76 years) and fewer deviations of 1.5 years or more (1.7% vs. 6.4%).
BoneXpert, which carries the CE Mark and has been in clinical use in Europe since 2009, will be released in the U.S. in early October, Visiana said.
