Ultrasonometer Cleared by FDA

Food and Drug Administration (FDA). Doctors can use the quantitative results as an aid in diagnosing osteoporosis and determining the risk for atraumatic associated fractures.

Osteoporosis is most often diagnosed through the use of large, x-ray-based bone density machines or after a fracture has occurred. The new portable ultrasonometer, called Qus-2, incorporates dry scanning technology that locates an optimal measurement site within the heel, ensuring a high level of performance, according to Quidel Corp. (San Diego, CA, USA; www.quidel.com), which markets the device. The Qus-2 is a self-contained, battery-operated device that weighs only seven pounds and can be used anywhere. The device is manufactured in an ISO 9001 certified facility and is approved to carry the CE Mark.

"We found that the Qus-2 is a reliable and reproducible method for identifying women with osteoporosis,” noted Susan Greenspan, M.D., University of Pittsburgh School of Medicine, a principal investigator for clinical trials conducted with the Qus-2. "Its ability to discriminate fracture status is similar to that of x-ray bone density techniques of the spine and hip.”



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