Diagnostic imaging  

US FDA clears GE Healthcare's new bone mineral density system

30 October 2005

Milwaukee, USA. GE Healthcare has announced that it has received U.S. Food and Drug Administration (FDA) clearance for its Lunar iDXA(TM), a new bone mineral density system designed to help doctors detect, diagnose and monitor treatment of osteoporosis, a disease characterized by low bone mass and increased risk of fracture, more accurately and earlier in the disease process. The system also enables clinicians to simultaneously assess body fat composition and ascertain fat distribution.

In addition, GE's iDXA is capable of measuring patients up to 400 lbs., which will help clinicians assess and diagnose larger patients, including professional athletes who traditionally have not been able to receive a comprehensive fitness diagnosis due to their size.

"The new iDXA provides both excellent image quality and precise bone density measurements to help clinicians diagnose osteoporosis," said Dr. Ken Faulkner, chief scientist for GE Healthcare's Lunar business. "The system can also determine regional body fat composition, which is an important indicator of risk for diabetes and cardiovascular disease."

Bone mineral density technology, usually referred to as dual-energy X-ray absorptiometry (DXA), is a rapid, precise, and accurate method for bone density assessment and the measurement of regional and total body composition in both clinical and research settings. The total body scan is one of the fastest growing DXA procedures due to its unique ability to provide data to clinicians on bone health and body composition. Clinicians can utilize this data to see the effects of a variety of metabolic disorders and their potential impact on bone health and body composition.

GE's iDXA will enable clinicians to detect changes in patients' bone density faster than before by offering extremely precise measurement of bone, allowing them to better assess bone mineral density, bone structure and ultimately bone strength, according to Faulkner. As a result, clinicians can monitor a patient's progress and response to therapy earlier in the treatment process by tracking changes in bone health that had previously been too minor to detect.

"iDXA images provide a substantial improvement in resolution and quality. I am extremely optimistic that this better image quality will improve the confidence with which we can identify vertebral fractures using DXA," said Dr. Neil Binkley, University of Wisconsin Osteoporosis Center in Madison, WI.

Once thought to be a normal part of aging, it is now known that osteoporosis can be slowed and fractures avoided with early detection and treatment. According to a 2004 U.S. Surgeon General's report on the nation's bone health, 10 million Americans over the age of 50 have osteoporosis, while another 34 million are at risk for developing the disease. In addition, approximately 1.5 million bone fractures per year are attributable to osteoporosis and health care expenditures related to osteoporosis are estimated to be $18 billion per year, also according to the Surgeon General's report.

"GE's iDXA system increases the opportunity of an improved diagnosis for our patients," said Jennie Hanson, president of Lunar. "In many cases, osteoporosis can be successfully treated if doctors can detect and intervene early. And for patients who've been diagnosed with osteoporosis, the trick is motivating them to stay on their treatment plans. Osteoporosis treatment takes time, and earlier feedback on progress can give patients incentive to stay the course."

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