FDA 510(k) Clearance for the Second Generation Bindex Point-of-Care Device

Bone Index Ltd., one of Europe’s top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the second generation Bindex point-of-care device model to help in osteoporosis diagnosis.

The use of Bindex advancing the way osteoporosis is diagnosed all over the world. This new technology is used in the world’s largest osteoporosis screening campaign. On May 2016, Bone Index Ltd. received 510(k) clearance for the first generation Bindex model.

Undiagnosed osteoporosis is a worldwide challenge. In the US alone osteoporosis is responsible for two million broken bones every year, costing over 19 billion dollars. Experts forecast that by 2025, the costs will rise to 25.3 billion dollars. One of the biggest challenges is the limited availability of osteoporosis diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs. “This is why Bindex is a game-changer,” says Bone Index’s CEO, Dr. Ossi Riekkinen.

Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA. Bindex detects osteoporosis with 90 percent sensitivity and specificity and will significantly help physicians with diagnosis.

“The clearance process with the FDA was very fast, only 6 months, thanks to our World’s top class R&D team. The technique is based on extensive clinical evidence with over 2500 patients and the position in the current care of osteoporosis is clear,” says Bone Index’s CTO, Dr. Janne Karjalainen.

“Bindex is unique technology. Now we have a total of 19 patents globally including the US, China, Japan and large European countries. The United States is a very significant market and we are actively seeking a partner who has the capabilities to take advantage of this unique opportunity. The overall aim is to prevent osteoporotic fractures and improve the quality of life of families in the US,” Dr. Riekkinen concludes.