Delphinus Awarded 510(k) Clearance for Color Imaging with SoftVue™ Automated Breast Ultrasound
Unparalleled Tissue Characterization Based on Transmission Signals
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.
“We are thrilled with this latest clearance,” said Mark Forchette, president and chief executive of Delphinus. “Our SoftVue technology presents imaging information in a way never realized previously. We can now distinguish breast tissue properties exhibited through a remarkable colorized display, achieved by our unprecedented design that measures the transmission of sound passing through tissue. This is yet another advancement that builds on our foundation of regulatory success, inspiring our team to innovate new solutions in breast cancer imaging.”
This novel color presentation is a major enhancement to the concepts behind elastography. By measuring and combining the quantitative values of sound speed and attenuation from signals that pass through tissues, a cross-sectional color image map is created 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 assist physicians discriminate areas of concern that may require further investigation.
“Our approach is unique because it characterizes tissue properties throughout the entire volume of the breast and it does not require a separate exam, an additional imaging sequence, or a contrast agent,” states Neb Duric, PhD, Chief Technology Officer and co-founder of Delphinus. “The radiologist is presented with both reflection and color imaging at the same time within the same study”.
About Delphinus Medical Technologies, Inc.
Delphinus Medical Technologies, Inc. is a pioneering medical imaging company that has developed SoftVue™, the first circular array transducer technology that has received U.S. Food and Drug Administration clearance. The patented technology is a whole breast ultrasound tomography imaging device that delivers no radiation, requires no compression, and images the entire breast with a single scan. SoftVue is indicated for use as a B-mode ultrasonic imaging system and is not intended to be used as a replacement for screening mammography. Delphinus is capitalized through principal investments by Arboretum Ventures, Ann Arbor, Mich., Beringea, Farmington Hills, Mich., and North Coast Technology Investors, Ann Arbor, Mich. For more information, visit www.delphinusmt.com.
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Delphinus Medical Technologies, Inc.
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