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News From the Food and Drug Administration
May 6, 1998

Ultrasound Device for Evaluating Bone Strength Approved

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JAMA. 1998;279(17):1339. doi:10.1001/jama.279.17.1339-JFD80003-2-1

The FDA has approved an ultrasound device (Sahara Clinical Bone Sonometer, Hologic, Inc, Waltham, Mass) for use in conjunction with assessment of other clinical risk factors to aid in the diagnosis of osteoporosis and estimation of fracture risk. The portable device transmits sound waves through the patient's heel and measures the speed and attenuation of sound through bone. Studies have shown that measurements obtained with this device are as good as bone mineral x-ray densitometry measurements in assessing a patient's bone fracture risk. The essential prescribing information (labeling) for the product warns that the "Individualization of Treatment" and "Relationship Between Sahara Results and Bone Mineral Density Results Obtained by X-ray Densitometry" sections must be read to properly interpret results. It states that the results obtained with the sonometer may be used, along with other factors such as laboratory test results, radiographs, and family history, in the diagnosis of osteoporosis and estimation of fracture risk.