FDA approves pocket sized osteoporosis diagnostic device

Most doctors will likely order a bone density x-ray scan for patients at risk of osteoporosis, and not only is that an expensive method but it also requires a physician referral. Now, the FDA has cleared a pocket-sized osteoporosis diagnosis device that might help physicians make the process of diagnosing the disease a bit easier.

Bindex, measures the cortical bone thickness of the tibia and an algorithm calculates the Density Index. The company who created the device, Bone Index, says that the detection rate is 90 percent and will ultimately increase efficiency with physicians.

"The clearance process with the FDA was straightforward despite the novel approach introduced with Bindex. The technique is based on extensive clinical evidence, and with the effectiveness of Bindex, the current care of osteoporosis can be significantly improved," said Bone Index's CTO and Founder Janne Karjalainen, PhD, in a statement.

In a recent article published in Osteoporosis International, the company cited that by combining the Bindex test and the international fracture risk calculator (FRAX), physicians would also be able to provide results for patients who need medication.

“This is extremely important because an estimated 75 percent of osteoporosis sufferers are undiagnosed and without the treatment they need," said Partner Heikki Kröger, MD, PhD, professor at the Kuopio University Hospital in Joensuu, Finland.