Tomographic ultrasound developer Delphinus Medical Technologies has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SoftVue whole-breast ultrasound tomography system.
SoftVue uses ring transducer technology to transmit and receive ultrasound signals, capturing reflection echoes from all directions around the breast and gathering transmitted signals coming through the breast, Delphinus said.
While traditional ultrasound looks at only a limited area of breast tissue, SoftVue provides a complete map of the whole breast, according to the company. And unlike traditional ultrasound where the outcome of the exam is dependent on operator skill and experience, SoftVue exams are consistent and uniform, removing user variability, Delphinus said.
