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Hologic wins US FDA approval for Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology for breast cancer screening.

M2 EQUITYBITES-March 28, 2018-Hologic wins US FDA approval for Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology for breast cancer screening

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Medical technology company Hologic Inc (Nasdaq:HOLX) revealed on Tuesday the receipt of US Food and Drug Administration (FDA) PMA approval for the Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology on the 3Dimensions breast tomosynthesis system for breast cancer screening.

The company stated the 3Dimensions breast tomosynthesis system provides higher resolution 3D images for radiologists, enhanced workflow for technologists and a more comfortable mammography experience, with low-dose options, for patients. The 3D imaging technology provides highest resolution 3D images to accelerate screening and analysis and clearly reveal subtle lesions and fine calcifications to help pinpoint cancers early, regardless of breast size or density.

Additionally, the Genius 3D Mammography exam is only available on the company's Hologic 3D Mammography system. The Genius exam consists of a 2D and 3D image set, where the 2D image can be either an acquired 2D image or a 2D image generated from the 3D image set. The Genius exam detects 20-65% more invasive breast cancers and is the only mammogram approved by the US FDA as superior for women with dense breasts compared to 2D alone.

To date, the company has installed more than 5,000 3D Mammography systems throughout the US and is continuing to help ensure insurance coverage is available for all women.

According to the company, the 3Dimensions system has two features to improve patient satisfaction: The SmartCurve breast stabilization system is clinically proven to deliver a more comfortable mammogram without compromising image quality, workflow or dose. The Quantra 2.2 Breast Density Assessment Software enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings.

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Publication:M2 EquityBites (EQB)
Date:Mar 28, 2018
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