> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Clears Bone Index Osteoporosis Diagnostic
- URL: https://www.fdaweb.com/fda-clears-bone-index-osteoporosis-diagnostic/
- Published: 2016-05-16T12:00:00.000Z
- Updated: 2026-09-14T21:03:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135682

FDA has cleared a Bone Index 510(k) for the Bindex point-of-care instrument, which is intended to help in osteoporosis diagnosis. The device measures the cortical bone thickness of the tibia and its algorithm calculates a density index, a parameter which estimates bone mineral density at the hip as measured with dual-energy x-ray absorptiometry, according to the company. It detects osteoporosis with 90% sensitivity and specificity, it says, adding that the clinical validation for Bindex was conducted with over 2,000 patients.