European medical devices manufacturer Bone Index has obtained 510(k) clearance from the US Food and Drug Administration (FDA) for its second generation Bindex point-of-care device for diagnosing osteoporosis.
Last May, the company secured FDA approval for the first generation Bindex model.
Bindex will assess the cortical bone thickness of the tibia, while the algorithm will calculate the density index, which is a parameter that estimates bone mineral density at the hip as measured with DXA.
The device is said to detect osteoporosis with 90% sensitivity, helping the physicians to effectively perform diagnosis.
According to the company, the osteoporosis is responsible for two million broken bones every year in the US, costing over $19bn.
Bone Index CEO Dr Ossi Riekkinen said: “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.”
Bone Index CTO Dr Janne Karjalainen said: "The clearance process with the FDA was very fast, only 6 months, thanks to our World's top class R&D team.”
Bone Index is engaged in the development of measuring devices for osteoporosis screening and diagnosis.
Image: Bone Index’s Bindex point-of-care device. Photo: courtesy of PRNewsFoto / Bone Index Ltd.