According to the manufacturer, Delphinus Medical Technologies, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration for the SoftVue™ whole breast ultrasound tomography system, approved for diagnostic breast imaging.
This new ultrasound platform images the entire breast, and allows for Delphinus to become the first company to design and manufacture a breast ultrasound system that utilizes ring transducer technology to transmit and receive ultrasound signals.
New and improved technology
Traditional hand-held ultrasound and automated breast ultrasound systems obtain only reflected echoes returning in the direction of the linear transducer. The SoftVue system captures reflection echoes from all directions around the breast and gathers transmitted signals coming through the breast, something no other ultrasound system is capable of doing.
Paul McCreadie, managing director of Arboretum Ventures and Chairman of the Board of Delphinus, said in a statement:
We believe that the opportunity now is better than ever for SoftVue’s ultrasound system to advance the state-of-the-art in breast cancer diagnostics. The shortcomings of existing modalities are widely known, and SoftVue’s ability to provide early and accurate diagnostic information without the risk of radiation exposure will serve to improve women’s health.
No danger from exposure to radiation
The system works by having the patient lay prostate with her breast suspended in warm water. The ensuing imaging takes no more than two minutes and images the entire breast. Unlike mammography, there is no danger from exposure to radiation.
Added company CEO Mark Morsfield:
We are pleased to receive this clearance from the FDA for our innovative technology. With an experienced team dedicated to advancing breast imaging and women’s health, Delphinus is committed to assisting medical professionals better define and diagnose breast disease, while establishing a better patient experience that can be available for all women, regardless of age and without the concern of radiation or discomfort.
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