The U.S. Food and Drug Administration (FDA) has cleared AZmed's Rayvolve x-ray software for pediatric use.
The announcement comes two years after FDA clearance for the use of the software in adult fracture detection, according to AZmed.
A study with outpatient imaging network SimonMed Imaging played a key role in the clearance, AZmed said. The research included a dataset of 3,000 pediatric radiographs and demonstrated Rayvolve's sensitivity of 96%, specificity of 86%, and area under the curve of 94%.
The software received the CE Mark in Europe in 2021.
