For the project, called SoftVue Discover Breast Ultrasound Prospective Case Collection, patients will undergo screening digital mammography as well as SoftVue ultrasound exams. Information will be collected to determine SoftVue's ability to detect cancers not found on mammography alone, according to Delphinus.
The study will include 10,000 asymptomatic women with dense breast tissue across several U.S. centers, including Beaumont Hospital - Dearborn, Elizabeth Wende Breast Care, Mount Sinai Medical Center, St. Elizabeth Hospital - Appleton, SouthCoast Health Imaging, the University of Southern California's Norris Comprehensive Cancer Center, and Weinstein Imaging Associates.
Data from the study will support the company's submission of a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA) for use of SoftVue in combination with mammography for women with dense breasts, according to the firm.
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