Gleamer gets FDA nod for AI fracture detection software

By staff writers

March 2, 2022 -- The U.S. Food and Drug Administration (FDA) has cleared Gleamer's BoneView artificial intelligence (AI)-based software, which detects bone fractures on x-rays.

BoneView detects fractures in x-rays and presents them to radiologists for final validation. The software's algorithm is cleared as a computer-assisted detection and diagnosis (CADe/CADx) application and highlights regions of interest with bounding boxes around areas where fractures are suspected so radiologists can prioritize reading those x-rays.

The software is currently available in the U.S. through Gleamer, Fujifilm Medical Systems, Aidoc, Ferrum Health, and Blackford Analysis. BoneView is already being used in 13 countries in Europe, Asia-Pacific, and North America.

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