FDA Approves New Breast Scan Device
Device Designed for Early Detection of Breast Cancer
March 10, 2004 -- The FDA has approved a new breast-scanning
device that uses digital infrared imaging to help in the early detection of
Researchers say the device, BreastScan IR, does not replace
traditional mammography or ultrasound for breast cancer screening. But the
device can draw attention to potential areas of concern that may not have been
detected by standard mammograms.
According to the device's manufacturer, Infrared Sciences
Corporation, the entire BreastScan IR procedure takes approximately 10 minutes,
and the results are immediately available to the doctor.
Unlike with mammography, the procedure does not expose the
patient to any radiation, does not require compression of the breast, and the
breast is not touched in any way. The patient (disrobed from the waist up) sits
in a chair facing an infrared camera, while a nurse performs the procedure.
The infrared camera measures various temperature variations
within the breast that might indicate areas of concern. These measurements are compared with measurements in a database,
and the findings are quantified by a computer to indicated specific areas of
BreastScan IR Aids in Early Detection of Breast Cancer
The FDA based its approval on clinical trials involving more
than 2,000 women that showed the device was useful as an additional aid in the
early detection of breast cancer.
"It will be used to provide doctors with an automated,
real-time report for use as an adjunctive test for doctors to use along with
mammography, ultrasound, or clinical examination," says Infrared Sciences
president, Thomas DiCicco, in a news release. "While infrared imaging has
been in use with varying degrees of success for more than 20 years, BreastScan
IR adds a fully automated digital element that greatly increases the
effectiveness and repeatability of the technology in determining breast
Researchers say the major advantage of the device is that it
can identify areas beneath dense breast tissue that mammograms can't image. It
can also detect areas that merit further testing with ultrasound.