FDA clears GE's contrast-enhanced mammo technology

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GE Healthcare’s SenoBright Contrast Enhanced Spectral Mammography (CESM) has received FDA 510(k) clearance.

SenoBright CESM technology is designed to produce contrast-enhanced images of the breast using a legally approved x-ray contrast agent and a dual energy acquisition technique. It uses x-rays at multiple energies to create two separate but almost simultaneous exposures. One image looks like a standard mammography image and a second image shows the contrast enhanced areas that can help localize a lesion.

SenoBright was originally launched in 2010 and is in use at 17 mammography centers throughout Europe and Japan, according to Waukesha, Wis.-based GE Healthcare.

GE estimated that by 2020, more than one million women worldwide will be examined using SenoBright.