Hologic's mammography system achieves premarket approval
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Hologic's Marlborough location
A high-resolution mammography system from Marlborough medical device maker Hologic has received premarket approval from the U.S. Food and Drug Administration for advanced 3D imaging.
The company’s Clarity HD three-dimensional system and its Intelligent 2D imaging technology are now available on the 3Dimensions breast tomosynthesis system using a low-dose x-ray system and a more comfortable mammography experience, according to a Hologic announcement Tuesday morning.
In a statement, the company’s Breast and Skeletal Health Solutions President Pete Valenti said the 3Dimensions system represents a major breakthrough in breast cancer screening technology with its image clarity regardless of breast size or density and increased comfort.
The system is designed to provide a quick, high-resolution three-dimensional image able to reveal subtle lesions and fine calcifications to help detect the earliest cancers.
The system was developed to help radiologists and technologists in diagnosing breast cancer and more accurately pinpointing the location to target treatment, said Tracy Accardi, the company’s global vice president of research and development.
Two of the company’s trademark inventions will accompany the newly-approved system: the SmartCurve breast stabilization system for improved comfort and the Quantra 2.2 Breast Density Assessment Software.
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