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FDA greenlights GE’s SenoBright HD clinical application for breast cancer diagnosis

por John R. Fischer, Senior Reporter | November 20, 2017
Women's Health
GE Healthcare’s SenoBright HD clinical application will soon be available to aid in the diagnosis of breast cancer across the U.S., following its recent approval by the FDA.

The next-generation Contrast-Enhanced Spectral Mammography (CESM) exam is available on the Senographe Pristina and is used to clarify inconclusive mammograms or ultrasounds as well as cases in which patients are at high risk for breast cancer.

“Mammograms are the most widely used and reliable technique for breast imaging,” Barbara Rhoden, the regional product marketing director for GE Healthcare Women’s Health U.S. and Canada, told HCB News. “Following an ambiguous mammogram and ultrasound - which can be caused by dense breasts - or for patients who are at high risk of having breast cancer, radiologists often need complimentary imaging solutions that deliver better visualization of breast lesions.”

During the exam, patients are injected with an iodine contrast agent to acquire a standard four-view mammogram. Multiple x-ray exposures of the breast reduce background signal, enabling the contrast agent with SenoBright HD to highlight areas of unusual blood flow, a possible indication of the presence of a malignant tumor as cancerous tissue relies on more blood for food and oxygen.

The contrast-enhanced mammogram uses high specificity to reduce false-positives and helps prevent unnecessary biopsies, surgeries and MR scans. SenoBright HD provides clear image quality and improves acquisition time by 40 percent in women with large breasts by reducing motion artifacts on images, compared to the first generation of GE CESM technology.

Exam time is typically less than seven minutes, with images immediately available for review by radiologists. The device is also a less expensive diagnostic alternative compared to MR, which not all facilities have access to, the results of which may not be immediately available, and which can often produce false positives due to its high sensitivity.

CESM can reduce staffing costs and time required for MR exams with research showing a 53 percent reduction in equipment costs and a 59 percent reduction in staffing costs in facilities that used it. The exam may also be a more comfortable option, as women also may refuse an MR exam due to feelings of anxiety.

Rhoden says the addition of SenoBright HD will decrease these feelings and allow for quicker diagnosis.

“Though it’s not every day that a patient needs further testing due to an inconclusive mammogram, when she does, we know that every minute waiting for a definitive answer can seem like an eternity,” she said. “We are seeing an increasing demand and interest in CESM. By performing a SenoBright HD exam in the same room, and on the same mammography equipment, patients can receive their diagnosis in a matter of minutes, rather than days, helping to reduce anxiety.”

Senobright HD is available for sale globally.

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