AZmed nabs FDA clearance for x-ray fracture detection software

By AuntMinnie.com staff writers

June 17, 2022 -- 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.


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