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Indication for Use & Safety Information

OsteoProbe is a measurement tool intended to assess bone tissue resistance to microindentation on the tibia of adults, reported as the Bone Material Strength Index (BMSi). In laboratory studies, BMSi measurements have been shown to correlate with biomechanical properties of bone, including whole-bone strength and fracture toughness. The clinical significance of laboratory-based biomechanical studies is unknown. The device is not intended to diagnose disease, predict fracture risk, or treat any clinical condition. Prescription use only, by or on the order of a physician.

FDA De Novo DEN210013; 510(k) K250216. CPT® Category III code 0547T; coverage varies by payer.

BoneScore

A direct, radiation-free measure of bone material strength. Built by Active Life Scientific, Inc.

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