Bone Index secures US FDA 510(k) clearance for Bindex

Finland-based medical device company Bone Index has secured US Food and Drug Administration (FDA) 510(k) clearance for its Bindex point-of-care instrument to assist in osteoporosis diagnosis.

Osteoporosis is claimed to be responsible for two million broken bones annually in the US, subsequently leading to a spiraling cost to treat the fractures which is projected to increase to $25.3bn by 2025.

Osteoporosis management currently faces the biggest challenge of low-availability of diagnostics, since bone density scans are generally performed in hospitals with large DXA X-ray machines that require high-costs.

Bone Index CEO Dr Ossi Riekkinen 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 thickness of the cortical bone of the tibia and the algorithm calculates the density index, a parameter which determines bone mineral density at the hip as measured with DXA.

The technology is said to detect osteoporosis with 90% sensitivity and specificity and is expected to assist the physicians with diagnosis.

Kuopio University Hospital department of orthopedics and traumatology professor Heikki Kröger said: "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."

More than 2000 patients have been administered with this technology to attain the clinical validation of Bindex.

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Image: Illustrated contrast between a normal standing posture and osteoporosis. Photo: courtesy of BruceBlaus.