OSI Systems said its Osteometer MediTech subsidiary has received premarket approval (PMA) from the Food and Drug Administration for its UltraSure DTU ultrasound scanner. The Hawthorne, CA-based vendor says the scanner is the first to be approved in the U.S. for assessing osteoporotic fracture risk.
The system measures broadband ultrasound attenuation and also provides high-resolution imaging, according to OSI. The imaging process identifies the precise location where a scan takes place on a patient’s calcaneus. By graphically pinpointing the region of interest, OSI believes the system provides greater accuracy, since a patient’s heel size and foot positioning during the scan become less crucial to an accurate reading.
By AuntMinnie.com staff writersSeptember 26, 2000
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