Technology | December 08, 2014

FDA Clears Color Stiffness Imaging for Delphinus' SoftVue Automated Breast Ultrasound

New feature creates cross-sectional color image map based on tissue characteristics

December 8, 2014 — Delphinus Medical Technologies Inc. announced receipt of another U.S. Food and Drug Administration (FDA) 510(k) clearance for  the SoftVue automated breast ultrasound during the annual meeting of the Radiological Society of North America, held in Chicago Nov. 30-Dec. 5.

This additional regulatory clearance, granted less than a year after obtaining the first 510(k), depicts color imaging based on tissue characteristics from the capture of transmission signals. Powered with circular, volumetric transducer technology, SoftVue is engineered with a proprietary process of 360 electronic sequencing, enabling transducer elements to both send and receive signals. Traditional hand-held ultrasound and other automated breast ultrasound systems obtain only reflected echoes returning in the direction of the transducer. By contrast, SoftVue captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, something no other ultrasound system, currently available, can do.

This novel color presentation measures and combines the quantitative values of sound speed and attenuation from signals that pass through tissues, creating a cross-sectional color image map using an established color spectrum, signifying the least to greatest relative tissue stiffness of the full volume of breast tissue. Along with the reflection image, the color analysis is utilized to help physicians discriminate areas of concern that may require further investigation.

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