The Food and Drug Administration (FDA) has granted premarket approval to the SoftVueTM 3D Whole Breast Ultrasound Tomography System (Delphinus Medical Technologies) for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue.

The SoftVue exam process begins with the patient laying on her stomach with her breast submerged in a warm water reservoir. Using a soft gel guide, the breast is stabilized and centered; imaging is then performed with a 360-degree ring transducer in 2mm intervals. The signals are then analyzed using algorithms that provide cross-sectional slices of the entire breast tissue.

The approval of the SoftVue system was based on a prospective case collection study that included over 8500 asymptomatic patients in “c” or “d” density categories at 10 breast imaging centers in the US. Compared with full field digital mammography alone, SoftVue detected and distinguished between normal and abnormal lesions with an increase in both sensitivity of 20% and specificity of 8%.

“It is exciting to have a new cutting-edge technology that detects more cancers and does so with fewer biopsies,” said Dr Rachel Brem, director for breast imaging at George Washington University Hospital, Washington DC and a member of Delphinus’s board of directors. “The FDA clearance for same day imaging optimizes workflow while providing unparalleled patient comfort with no compression or radiation, will make patient screening more comprehensive, efficient and effective.”


Delphinus receives FDA approval for its SoftVue 3D Whole Breast Ultrasound Tomography System. News release. October 12, 2021.