Gleamer gets FDA nod for AI fracture detection software

2019 04 04 21 52 2230 Artificial Intelligence Ai Data 400

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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