News

Delphinus Awarded 510(k) Clearance for Color Imaging with SoftVue™ Automated Breast Ultrasound

Unparalleled Tissue Characterization Based on Transmission Signals

Fri Dec 12 2014By Other Author

PLYMOUTH TOWNSHIP, Mich. – December 2, 2014 – Delphinus Medical Technologies, Inc., the first company to design and manufacture an automated whole breast ultrasound system that incorporates circular transducer technology, announced during the annual meeting of the Radiological Society of North America held in Chicago, Ill., receipt of another 510(k) clearance for SoftVue™ from the U.S. Food and Drug Administration.

This additional regulatory clearance, granted less than a year after obtaining the first 510(k), is truly unique, depicting 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 ultrafast 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.

To read the full article visit Delphinus Medical Technologies, Inc. website

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