GE Healthcare has received U.S. Food and Drug Administration (FDA) 510(k) clearance for SenoBright HD, the latest version of its contrast-enhanced spectral mammography (CESM) technology.
Available on GE's Senographe Pristina full-field digital mammography system, SenoBright HD is designed to be used after an inconclusive mammogram or ultrasound scan, or for patients who are at high risk of having breast cancer, according to the company.
With SenoBright HD, a woman is administered an iodine contrast agent to acquire a standard four-view mammogram. Multiple x-ray exposures of the breast are acquired to reduce background signal, and areas of unusual blood flow, which could indicate malignant tissue, are highlighted.
Compared with the first generation of SenoBright, the new HD version produces clear image quality and reduces acquisition time by 40% in women with large breasts by reducing motion artifacts. The entire exam typically takes seven minutes, GE said.
