Bone Index Receives FDA Clearance for POC Osteoporosis Test

Point-of-care bone density test could be a “game-changer”, according to its Finnish developers.

Finland-based firm Bone Index said Friday that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for a second-generation point-of-care diagnostic test for osteoporosis.

The test, Bindex, uses ultrasound to measure the cortical bone thickness of the tibia and applies an algorithm to calculate the bone density index, an estimate of bone mineral density, at the hip. Bindex detects osteoporosis with 90% sensitivity and specificity, Bone Index said, and noted that its technique is based on clinical evidence from more than 2,500 patients. Its first-generation test received 510(k) clearance in May 2016.

In the US, osteoporosis causes for 2 million broken bones each year, costing over $19 billion, Bone Index said.

One of the biggest challenges is the limited availability of osteoporosis diagnostics because bone density scans are done frequently in hospitals with large bone densitometry x-ray machines that entail high costs. Therefore the Bindex POC device could be a “game-changer,” the firm said.

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