Guided By Research
The science behind SoftVue™ is based on several years of ultrasound research conducted within technical and clinical domains. The data has demonstrated the benefits this technology can bring to the challenges of finding breast disease at an early stage in dense breast tissue.
Clinical Study Summary
The Delphinus Pivotal Retrospective Reader Study (DMT-2019.002) was an analysis of radiologist image interpretation performance utilizing prospectively collected patient data obtained from the Discover SoftVue Prospective Case Collection (PCC) (DMT-2015.001). The patient data utilized in the reader study was collected from a total of six PCC Registry clinical sites across the U.S. The retrospective analysis performed was an observational case-controlled, multi-reader, multi-case Receiver Operating Characteristic (ROC) study involving 32 Readers who were MQSA qualified radiologists with experience in breast image interpretation. The cases were comprised of bilateral full-field digital mammography [FFDM] and SoftVue (SV) screening imaging acquired from the same patient during the same screening interval. There were one hundred and forty (140) cases sampled for the reader study from a pool of asymptomatic female volunteers with BI-RADS c or d breast density. The reader study provided pivotal data on AUC improvement, sensitivity, and specificity of SoftVue as a screening tool in comparison with digital mammography. A complete summary of the reader study endpoint results is provided in the SoftVue Physician Labeling. Additional SoftVue published research is highlighted below.