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Delphinus receives FDA approval for its SoftVue 3D whole breast ultrasound tomography system

Press releases may be edited for formatting or style | October 12, 2021 Health IT Ultrasound Women's Health
NOVI, Mich.--(BUSINESS WIRE)--Delphinus Medical Technologies, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of its SoftVue™ 3D Whole Breast Ultrasound Tomography System (SoftVue™) for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone. The SoftVue exam is completed with no compression or radiation, and the PMA indication for use allows SoftVue exams to be performed at the same appointment as screening mammograms, facilitating a streamlined workflow and rapid delivery of results.

“SoftVue plus mammography finds more cancers when screening women with dense breasts. 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. 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.

SoftVue was developed to address the unmet clinical needs for early breast cancer detection in individuals with dense breast tissue (fibrous tissue that can hide cancerous lesions on mammogram) and provides a new annual screening solution for this population. The system identifies more cancers, with fewer callbacks, using a proprietary TriAD™ (Triple Acoustic Detection) technology that effectively characterizes tissue by recording reflection, speed and direction of sound waves moving through breast tissue, unlike traditional ultrasound which utilizes only reflection.

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During the exam, the patient relaxes on her stomach with her breast submerged in a warm water bath. The breast is comfortably stabilized and centered with a disposable Sequr™ Breast Interface gel pad. Imaging is performed with a proprietary 360-degree ring transducer, scanning each breast from chest wall to nipple in an average of three minutes, capturing new images every two millimeters. The captured signals are then analyzed using sophisticated algorithms that provide cross-sectional slices of the entire volume of breast tissue.

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