Delphinus Medical Technologies, Inc. announces that the U.S. FDA has granted premarket approval (PMA) of its SoftVue 3D Whole Breast Ultrasound Tomography System for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. 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,” says Rachel Brem, MD, director for breast imaging at George Washington University Hospital in Washington, D.C., 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.
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 3 minutes, capturing new images every 2 mm. The captured signals are then analyzed using sophisticated algorithms that provide cross-sectional slices of the entire volume of breast tissue.
“Our SoftVue System delivers a breakthrough in tissue characterization and improves the ability to find cancers in dense breast patients. It will be a game changer that will transform clinical practice with a fundamentally new, and highly impactful approach,” says Mark J. Forchette, president and chief executive officer at Delphinus. “The SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”