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FDA adds OssView bone fragility software to breakthrough program

FDA adds OssView bone fragility software to breakthrough program

Melbourne, Australia-based CurveBeam AI is investigating how calculating a Structural Fragility Score, or SFS – a bone fragility measure – can support clinical decisions and improve patient care.

OssView is not yet available for sale in the United States, but the FDA Breakthrough Devices Program speeds up development, assessment and review, while preserving the agency’s standards for premarket approvals, according to the announcement. 


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