Orthopedic-focused Finnish med device manufacturer Bone Index said today it won FDA 510(k) clearance for its 2nd-generation Bindex point-of-care device designed to aid in diagnosing osteoporosis.
The company’s Bindex device is designed to measure the cortical bone thickness of the tibia, and uses an algorithm to calculate a “density index”, which Bone Index said estimates the bone mineral density at the hip.
The device can detect osteoporosis with a 90% sensitivity and specificity, according to Bone Index.
“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. 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,” CTO Dr. Janne Karjalainen said in a press release.