Bone Index Receives FDA Clearance for POC Osteoporosis Test
Finland-based Bone Index said Friday that it has received 510(k) clearance from the US Food and Drug Administration 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 percent sensitivity and specificity, the firm said, and noted that its technique is based on clinical evidence with more than 2,500 patients. Its first generation test received 510(k) clearance in May 2016.
In the US, osteoporosis is responsible 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 is a “game-changer,” the firm said.