FDA Approves GE’s SenoBright Spectral Mammography Device

The U.S. Food and Drug Administration (FDA) has cleared GE Healthcare’s SenoBright contrast enhanced spectral mammography (CESM) unit, the company announced on Thursday.

The technology is designed to produce contrast-enhanced images of the breast using an X-ray contrast agent and a dual energy acquisition technique. SenoBright uses X-rays at multiple energies to create two separate but almost simultaneous exposures. The resulting images illuminate and highlight areas of iodinated contrast. SenoBright is already in use at 17 major mammography centers in France, Spain, Italy, Belgium, Germany, Austria, and Japan, GE said.

“CESM presents two images per mammographic view, one that looks like standard mammography and a second image that shows the contrast enhanced areas that can help localize a lesion. As the images are familiar, it can therefore be easily reviewed by surgeons and oncologists. Moreover in terms of workflow, a CESM exam takes from five to 10 minutes,” said Dr. Clarisse Dromain, Gustave Roussy Cancer Institute, France.

SenoBright is intended to allow for a procedure to be conducted by the same staff, using the same mammography equipment, potentially on the same day as a traditional screening exam, thereby helping medical professionals to cut the critical time patients often have to wait from detection to diagnosis, the company said. GE said the 2,500 Senographe DS and Senographe Essential digital mammography systems in use today are upgradeable to SenoBright.