Delphinus Medical Technologies has received a second (510)k clearance from the Food and Drug Adminstration for its SoftVue automated whole breast ultrasound system. The regulatory clearance comes less than a year after SoftVue’s first 510(k) clearance.
“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.”
The SoftVue system presents color images based on tissue characteristics from the capture of transmission signals. Using circular, volumetric transducer technology, SoftVue captures transmitted signals reflected around and through the breast. This technique is not currently available with any other ultrasound system. The latest novel color presentation feature enables generation of a cross-sectional map color-coded to indicate the areas of least to greatest relative tissue stiffness across the full volume of breast tissue. The tool can help clinicians identify areas of concern that may bear 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,” said Neb Duric, PhD, chief technology officer and cofounder of Delphinus. “The radiologist is presented with both reflection and color imaging at the same time within the same study.”
For more information, visit Delphinus Medical Technologies.