Women's imaging firm Hologic said the U.S. Food and Drug Administration (FDA) has approved its premarket approval (PMA) application for the Clarity HD and Intelligent 2D imaging technologies.
Aimed at speeding up screening and analysis, Hologic's Clarity HD high-resolution 3D imaging technology is designed to reveal subtle lesions and fine calcifications, according to the vendor. Clarity HD's detector and 3D imaging algorithm team up to deliver high-quality 3D images, regardless of breast size or density, the company said.
In addition, Hologic said that its new Intelligent 2D imaging technology works with Clarity HD to enhance image quality and provide clarity, contrast, and detail at a lower dose. Both Clarity HD and Intelligent 2D imaging are now available on the firm's 3Dimensions digital breast tomosynthesis (DBT) system.
In other 3Dimensions developments, the company has added SmartCurve, a breast stabilization system for providing more comfortable mammograms without negatively affecting image quality, workflow, or dose. What's more, Hologic has released version 2.2 of its Quantra breast density assessment software, which utilizes a machine learning-based algorithm.
Hologic also reported that it has now installed more than 5,000 DBT systems in the U.S.
