FDA Clears Delphinus Breast Ultrasound Tomography System

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Delphinus Medical Technologies Inc. of Plymouth Township, Mich., has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its SoftVue™ whole breast ultrasound tomography system.

According to the company, SoftVue is unique because it uses ring transducer technology to transmit and receive ultrasound signals when creating 3D breast ultrasound images. Traditional hand-held ultrasound and automated breast ultrasound systems obtain only reflected echoes returning in the direction of the linear transducer. By contrast, SoftVue captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, the company noted in its press release.

An added benefit of the system is that it is not dependent on the skill of the technologist operating the system for the quality of its images and it is more comfortable for patients as it requires no compression of breast tissue.

Delphinus is a spin-off of the Barbara Ann Karmanos Cancer Institute (KCI). The primary investor in the company is Arboretum Ventures, a venture capital firm based in Ann Arbor, Mich., that specializes in the health care sector.

The global breast Imaging market is one of the fastest growing multi-billion dollar markets in the health care industry, according to market research firm Markets and Markets. A 2013 M &M report put the global breast Imaging market compound annual growth rate (CAGR) of 15.37% and predicted the breast imaging market will reach about $5 billion by 2017.