Hand-Held Osteoporosis Test Cleared by FDA

The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to Bone Index Ltd.’s Bindex point of care instrument to diagnoses osteoporosis. Bone Index was founded in 2011 in Kuopio, Finland, and specializes in the development of measuring devices for osteoporosis screening and diagnosis.

Bone Index’s CEO, Ossi Riekkinen, M.D. said, “Bindex technology is unique in the world. The device is pocket-sized, reliable and enables new and cost-effective diagnostic pathways for osteoporosis.”

Bindex measures the cortical bone thickness of the tibia and the algorithm calculates the Density Index. According to the manufacturer, Bindex detects osteoporosis with 90% sensitivity and specificity and will significantly help physicians with diagnosis.

Osteoporosis is responsible for two million broken bones every year in the U.S. Costs of these fractures are about $19 billion. Experts forecast that by 2025, the costs due to bone fractures will rise to $25.3 billion.

One of the biggest challenges in osteoporosis management is the low availability of diagnostics, said Bone Index CTO Janne Karjalainen, M.D. He added, “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.”

Professor Heikki Kroger, M.D., estimates that 75% of osteoporosis sufferers are undiagnosed and go without receiving the treatment they need. He said that the clinical validation for Bindex was conducted with over 2, 000 patients.