FDA Approves New Breast Scan Device

Device Designed for Early Detection of Breast Cancer

Medically Reviewed by Brunilda Nazario, MD on March 10, 2004
From the WebMD Archives

March 10, 2004 -- The FDA has approved a new breast-scanning device that uses digital infrared imaging to help in the early detection of breast cancer.


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 concern.

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 health."

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.