The US Food and Drug Administration has given 510(k) clearance to Bone Index Ltd to market the second generation Bindex point-of-care device to assist in diagnosing osteoporosis.
The device measures the cortical bone thickness of the tibia, and the algorithm calculates the Density Index, a parameter that estimates bone mineral density at the hip as measured with DXA, explains a media release from Bone Index Ltd.
According to the Finland-based company, Bindex detects osteoporosis with 90% sensitivity and specificity.
“The clearance process with the FDA was very fast, only 6 months, thanks to our World’s top class R&D team,” says Bone Index’s CTO, Dr Janne Karjalainen, in the release.
“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,” Karjalainen adds.
[Source(s): Bone Index Ltd, PR Newswire]
