FDA Clears Delphinus’s Breast Ultrasound Tomography System

Delphinus Medical Technologies Inc., a Michigan-based ultrasound company, has received FDA 510(k) clearance for its whole breast ultrasound tomography system for diagnostic breast imaging.

The SoftVue system uses ring transducer technology to transmit and receive ultrasound signals. Traditional hand-held ultrasound and automated breast ultrasound systems obtain reflected echoes returning in the direction of the linear transducer, where this system captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, according to the company. There is currently no other ultrasound system available that does that, the company said.

The breast is suspended in warm water, and the exams are one to two minutes per breast, the company said. SoftVue provides a complete map of the whole breast, and the exam is more consistent and uniform than traditional ultrasound, according to the company.