Delphinus Medical Technologies announced today that it received FDA premarket approval (PMA) for its SoftVue system.
Novi, Michigan-based Delphinus develops the 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, according to a news release.
The company said SoftVue has proven capable of enhancing dense breast screening and identifying up to 20% more cancers with greater accuracy and potentially fewer biopsies than full-field digital mammography (FFDM) alone in clinical settings. The exam is completed with no compression or radiation and PMA allows for such exams to be performed at the same appointment as screening mammograms to improve workflow and speed the delivery of results.
SoftVue uses Delphinus’ proprietary TriAD (triple acoustic detection) technology to effectively characterize tissue by recording reflection, speed and direction of sound waves moving through breast tissue, contrary to traditional ultrasound, which only utilizes reflection.
In the exam, a patient relaxes on her stomach with her breast submerged in a warm-water bath while the breast is stabilized and centered with a disposable Sequr breast interface gel pad. Imaging is performed with a proprietary 360-degree ring transducer, scanning from chest wall to nipple in an average of three minutes as it captures new images every two millimeters.
“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,” Delphinus president & CEO Mark J. Forchette said in the release. “The SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”