FDA 510(k) Clearance for the Bindex®!
Bone Index Ltd., one of Europe's top new manufacturers of medical devices, has received 510(k) clearance from the Food and Drug Administration (FDA) for the Bindex® point-of-care instrument to help in osteoporosis diagnosis.
Osteoporosis, a very underdiagnosed disease, is responsible for two million broken bones every year in the USA. These fractures translate into costs totaling about 19 billion dollars. Experts forecast that by 2025, the costs due to fractures will rise to 25.3 billion dollars. Currently, one of the biggest challenges in osteoporosis management is the low availability of diagnostics since bone density scans are mostly performed in hospitals with large DXA X-ray machines that entail high costs.
Bindex® measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index, a parameter which estimates bone mineral density at the hip as measured with DXA. Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.
"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," says Bone Index's CTO, Dr. Janne Karjalainen.
"A recently published article* in Osteoporosis International presents an approach to how the international fracture risk calculator (FRAX®) and the Bindex® test can be used together in identifying patients in need of medication. This is extremely important because an estimated 75% of osteoporosis sufferers are undiagnosed and without the treatment they need," says Professor Heikki Kröger, MD. The clinical validation for Bindex® has been conducted with a total of over 2,000 patients.
"Bindex technology is unique in the world. The device is pocket-sized, reliable and enables new and cost-effective diagnostic pathways for osteoporosis," says Bone Index's CEO, Dr. Ossi Riekkinen.
For more information:
CEO Ossi Riekkinen
Professor Heikki Kröger
*Karjalainen et al. "New method for point-of-care osteoporosis screening and diagnostics," Osteoporosis International 2016 Mar;27(3):971-7.