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
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