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Back To Vidyya FDA Approval For Imaging Ultrasound Scanner

First Imaging Ultrasound System For Assessment Of Osteoporotic Fracture Risk

OSI Systems, Inc. announced that its Osteometer MediTech subsidiary has received a Pre-Market Approval (PMA) from the United States Food and Drug Administration (FDA) to market its UltraSure DTU-one ultrasound scanner in the United States. Although there are currently non-imaging ultrasound systems available in the United States marketplace, this product marks the first PMA granted for an imaging ultrasound system for assessment of osteoporotic fracture risk.

The DTU-one is a major break-through in the assessment of osteoporotic fracture risk as it creates a high-resolution image of the scanned bone, the calcaneus. This unique feature provides the definition of a specific region of interest (ROI) resulting in unsurpassed reproducibility. The DTU-one holds a considerable possibility for widespread clinical use, mainly related to its lack of radiation exposure and low cost.

"The approval from the FDA for the marketing of this imaging ultrasound scanner in the United States is an excellent development, as it opens up a potentially large market for us," stated Deepak Chopra, Chairman and CEO of OSI Systems. Osteoporosis is believed to affect over 25 million people in the U.S. alone, and thankfully there is a growing awareness of this potentially debilitating disease. Osteoporosis is treatable if diagnosed early and accurately, and the UltraSure DTU-one can greatly assist medical service providers to determine osteoporotic fracture risk."

Chopra added, "Our Osteometer MediTech subsidiary has been selling the UltraSure DTU-one scanner outside the United States, and has received consistently positive reviews from users of this innovative system. We believe that the time-tested history of the UltraSure DTU-one will enhance our ability to enter the market in this country."

The UltraSure DTU-one is a new generation of imaging ultrasound scanner which quickly and accurately measures the risk of osteoporotic fracture through non-invasive ultrasound technology. The system measures broadband ultrasound attenuation (BUA) and also provides high-resolution imaging. The imaging process identifies the precise location that a scan takes place on a patient's calcaneus (heel bone). By graphically pinpointing this 'region of interest (ROI)', the system provides for greater accuracy, as a patient's heel size and foot positioning during the scan become less crucial to an accurate reading. Through this high-resolution imaging process, the UltraSure DTU-one overcomes the limits of non-imaging ultrasound scanners currently on the market in the United States.

The UltraSure DTU-one is a 'turnkey' system designed for ease-of-use, which promotes rapid adoption and a reduction in staff costs.


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Editor: Susan K. Boyer, RN
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