Delphinus Receives Additional FDA Clearance for SoftVue

Tomographic ultrasound developer Delphinus Medical Technologies Inc. has received another 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its SoftVue system.

The additional regulatory clearance, granted less than a year after obtaining the first 510(k), was granted for 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, according to the company. 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.

“We are thrilled with this latest clearance,” Delphinus President/CEO Mark Forchette said.  “Our SoftVue technology presents imaging information in a way never realized previously. We can now distinguish breast tissue properties exhibited through a colorized display, achieved by our 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.”

SoftVue’s color presentation is a major enhancement to the concepts behind elastography, Delphinus executives said. 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 help 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,” said Neb Duric, Ph.D., 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.”

Delphinus Medical Technologies Inc., a Michigan-based company, developed SoftVue, the first circular array transducer technology that has received FDA 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.

Arboretum Ventures is a venture capital firm specializing in the healthcare sector. Founded in 2002, the firm manages $235 million in capital and has invested in more than 30 companies, five of which have exited with an aggregate valuation of approximately $1 billion. Arboretum invests throughout the United States, with a preference for Midwest opportunities, targeting capital efficient companies that can meaningfully reduce healthcare costs in key areas of expertise: devices, diagnostics, services, and IT.