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,
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
"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."