Bone Index receives FDA clearance
Bone Index 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.
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,” said Dr. Riekkinen.
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