AZmed was granted FDA 510(k) clearance for Rayvolve, a solution for detecting fractures on pediatric x-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection.
A study with SimonMed Imaging confirmed Rayvolve’s efficacy in clinical settings, further validating AZmed’s commitment to collaborating with healthcare leaders to advance medical imaging technology. Involving a dataset of 3,000 pediatric radiographs, the study demonstrated Rayvolve’s high sensitivity (96%) and specificity (86%), making it one of the most effective software for assisting radiologists in detecting fractures in children, with an Area Under the Curve (AUC) of 94%.
The plan to introduce Rayvolve to more U.S. healthcare professionals aims to enhance traditional methods by focusing on quicker fracture detection and reducing the impact of fatigue and workload on clinicians.
AZmed was granted FDA 510(k) clearance for Rayvolve, a solution for detecting fractures on pediatric x-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection.
A study with SimonMed Imaging confirmed Rayvolve's efficacy in clinical settings, further validating AZmed's commitment to collaborating with...
AZmed was granted FDA 510(k) clearance for Rayvolve, a solution for detecting fractures on pediatric x-rays. This milestone comes two years after receiving FDA clearance for adult fracture detection.
A study with SimonMed Imaging confirmed Rayvolve’s efficacy in clinical settings, further validating AZmed’s commitment to collaborating with healthcare leaders to advance medical imaging technology. Involving a dataset of 3,000 pediatric radiographs, the study demonstrated Rayvolve’s high sensitivity (96%) and specificity (86%), making it one of the most effective software for assisting radiologists in detecting fractures in children, with an Area Under the Curve (AUC) of 94%.
The plan to introduce Rayvolve to more U.S. healthcare professionals aims to enhance traditional methods by focusing on quicker fracture detection and reducing the impact of fatigue and workload on clinicians.
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