FDA News

FDA clearance granted for device to diagnose osteoporosis

The FDA recently granted clearance to Bone Index Ltd. for the second-generation Bindex point-of-care device model used in aiding diagnoses of osteoporosis, according to a company press release.

“The clearance process with the FDA was very fast, only 6 months. … The technique is based on extensive clinical evidence with over 2,500 patients and the position in the current care of osteoporosis is clear,” Janne Karjalainen, PhD, chief technology officer of Bone Index, said in the release.

Bindex calculates the density index by measuring cortical bone thickness of the tibia and identifies osteoporosis with 90% sensitivity and specificity.

“Bindex is [a] unique technology,” Ossi Riekkinen, PhD, CEO of Bone Index, said in the release. “Now we have a total of 19 patents globally including the [United States], China, Japan and large European countries. The United States is a very significant marker 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 [United States].”