February 2017

Bone Index device gets FDA clearance

Kupio, Finland-based Bone Index in January received 510(k) clearance from the US Food and Drug Administration for its second-generation point-of-care device for osteoporosis diagnosis.

The small handheld device uses ultrasound as alternative to dual-energy x-ray absorptiometry (DXA) bone densitometry to measure the tibia’s cortical bone thickness and calculate bone mineral density at the hip. It connects to a laptop running Bindex software and detects osteoporosis with 90% sensitivity and specificity, according to a company release.

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