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Medical Devices / Submissions and Approvals

Bone Index Gains FDA Clearance for Bindex

May 17, 2016
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Bone Index has secured FDA 510(k) clearance for Bindex, a point-of-care device designed for diagnosing osteoporosis, the Finnish devicemaker announced Monday.

The instrument measures the cortical bone thickness of the tibia to calculate bone density and detect osteoporosis with 90 percent sensitivity and specificity, according to the company. — Anisa Jibrell

 

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