Delphinus Medical Technologies Inc., a medical imaging company based in Novi, announced that the U.S. Food and Drug Administration has granted premarket approval (PMA) of its SoftVue 3-D Whole Breast Ultrasound Tomography System.
The system is designed for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. Clinical evidence has shown that SoftVue enhances dense breast screening and identifies up to 20 percent more cancers and potentially fewer biopsies than a traditional full field digital mammography (FFDM).
“SoftVue plus mammography finds more cancers when screening women with dense breasts,” says Dr. Rachel Brem, director for breast imaging at George Washington University Hospital and a member of Delphinus’ 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. It is exciting to have a new cutting-edge technology that detects more cancers and does so with fewer biopsies.”
The SoftVue exams is completed with no compression or radiation, and the PMA indication for use allows exams to be performed at the same appointment as screening mammograms. It was developed to address unmet clinical needs for early breast cancer detection in individuals with dense breast tissue.
The system identifies more cancers using a proprietary triple acoustic detection (TriAD) technology that characterizes tissue by recording reflection, speed, and direction of sound waves moving through breast tissue, unlike traditional ultrasound which utilizes only reflection.
The exam is conducted by having the patient relax their stomach with their breast submerged in a warm water bath. The breast is stabilized and centered with a disposable gel pad. Imaging is performed with a proprietary 360-degree ring transducer, scanning each breast from chest wall to nipple.
“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 CEO at Delphinus. “The SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”
Delphinus executed a Prospective Case Collection (PCC) study that served as the image database for the cancer and non-cancer cases that were subsequently used in a series of multi-reader, multi-case studies conducted by the University of Chicago.
The PCC initiative began in the summer of 2017 and enrolled more than 8,500 asymptomatic patients in c or d density categories at 10 leading breast imaging centers around the US. A team of radiologists analyzed more than three million coronal plane images generated by the initiative.
The studies results showed that SoftVue detects and distinguishes between normal and abnormal lesions with an increase in both sensitivity of 20 percent and specificity of 8 percent, as compared to FFDM alone. Additionally, 95 percent of patients surveyed after their SoftVue exam indicated that they would recommend SoftVue to other women.