The U.S. Food and Drug Administration (FDA) has cleared AZmed's Rayvolve software for detecting fractures on x-rays.
A clinical study conducted at University Hospitals in Cleveland, OH, found that Rayvolve increased reader accuracy for identifying fractures on x-ray by 5.6%, improved sensitivity from 86% to 95%, boosted specificity from 82% to 83%, and decreased review and interpretation time by 27%, according to the firm.
The software received CE marking in 2021 and is being used in more than 300 healthcare facilities in 21 countries around the world, AZmed said.
