FDA Clears Point-of-Care Device for Diagnosing Osteoporosis
The device connects to a laptop or desktop computer's USB socket
Bone Index announced that the Food and Drug Administration (FDA) has granted clearance for the second generation Bindex device model to aid in the diagnosis of osteoporosis.
Bindex is a point-of-care device that measures the cortical bone thickness of the tibia. Its algorithm then calculates the Density Index, which estimates bone mineral density at the hip as measured with DXA scan. Bindex is able to detect osteoporosis with 90% specificity and sensitivity and has proven to be an accurate instrument in diagnosing osteoporosis and evidence-based treatment decisions. This allows the identification of a patients at risk for osteoporosis before the occurrence of a first bone fracture.
Bindex provides results in 30 seconds allowing physicians to do more screenings and to prescribe necessary treatment. The device is plugged in a USB port and can be carried around to each patient.
The first generation Bindex device model was initially cleared by the FDA in May 2016.
For more information visit Bindex.fi.