GE Healthcare Garners FDA Clearance For SenoBright Technology

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GE Healthcare today announced that it has received 510(k) clearance from the Food and Drug Administration (FDA) for its SenoBright1 Contrast Enhanced Spectral Mammography (CESM) technology. Launched in 2010 and already in use at 17 major mammography centers in Europe and Japan, the 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 utilizes X-rays at multiple energies to create two separate, but almost simultaneous exposures. Areas of iodinated contrast are then specifically illuminated and highlighted in the resulting images. GE Healthcare estimates that 2,500 digital mammography systems upgradeable to SenoBright are currently in clinical use. To read the press release, click here: