New proposed FDA regulations could benefit Hologic mammography systems
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Hologic's Marlborough headquarters
Hologic, a maker of mammography systems, is applauding proposed rule changes from the U.S. Food & Drug Administration to place a bigger emphasis on breast density when screening for breast cancer.
The rule changes to mammography facilities are the first in 20 years and reflect the rise of new technologies in the breast health field, including breast density reporting, a specialty of Hologic.
Among the proposed changes is the addition of breast density information to mammography systems and rules to require doctors to inform patients about how breast density relates to breast cancer risk.
Among the proposed amendments to improve communication and medical decision making is the addition of breast density information to the mammography lay summary letter provided to patients and to the medical report provided to their referring healthcare professionals.
In a statement, Marlborough-based Hologic’s Beast and Skeletal Health Division President Pete Valenti commended the FDA for recognizing the importance of breast density reporting.
“Better informed patients make smarter decisions, like screening with the Genius exam, the only mammography exam FDA approved to find more cancers in dense breasts,” he said.
The 3D imaging Genius system, according to Hologic, is the only exam clinically proven to detect 20 to 65 percent more invasive breast cancers in dense breasts compared to 2D systems alone.
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