www.fdanews.com/articles/176661-bone-index-gains-fda-clearance-for-bindex
Bone Index Gains FDA Clearance for Bindex
May 16, 2016
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