Bone Index Receives FDA 510(k) Clearance for the Second Generation Bindex®!
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® is rapidly 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% 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.
Founded in 2011 and based in Kuopio, Bone Index Finland Ltd. specializes in the development of measuring devices for osteoporosis screening and diagnosis.
For more information:
Bone Index Ltd., Dr. Ossi Riekkinen, CEO,
firstname.lastname@example.org , +358-50-363-2797, www.bindex.fi/en/