Novi’s Delphinus Announces Third Installation of Breast Imaging System

Delphinus Medical Technologies Inc. in Novi has announced the latest installation of its SoftVue 3D Whole Breast Ultrasound Tomography System since receiving Food & Drug Administration (FDA) approval of its advanced technology for screening women with dense breast tissue.
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Rendering of SoftVue breast imaging hardware
Delphinus’ SoftVue breast imaging system can better detect cancer while reducing the incidence of false positives. // Photo courtesy of Delphinus

Delphinus Medical Technologies Inc. in Novi has announced the latest installation of its SoftVue 3D Whole Breast Ultrasound Tomography System since receiving Food & Drug Administration (FDA) approval of its advanced technology for screening women with dense breast tissue.

UR Medicine in Rochester, New York, is now the third medical center in the world offering dense breast cancer screening with SoftVue.

“SoftVue addresses the critical need for an effective, comfortable breast cancer screening solution for women with dense breasts,” says Mark J. Forchette, president and CEO of Delphinus Medical Technologies. “We are confident SoftVue screening will lead to saving lives and are excited to have University of Rochester embrace this leadership position at the forefront of a paradigm shift in breast cancer screening.

“Interest in SoftVue is advancing significantly around the country, and we have recently expanded our team, including appointing Scott White as chief commercial officer, to support our growing customer base and help interested sites advance their dense breast screening programs.”

SoftVue, a 3D whole-breast ultrasound tomography system for screening dense breasts, was approved by the FDA in October 2021. When paired with mammography, SoftVue has been shown to identify up to 20 percent more cancers while also reducing false positives and decreasing unnecessary callbacks and biopsies in women with dense breasts.

“Breast imaging radiologists are very aware of the limitations of mammography in women with dense breasts; at least 40 percent of U.S. women have dense breasts,” says Dr. Avice M. O’Connell, division head of breast imaging and professor of imaging sciences at the University of Rochester. “We need to do better, and 3D imaging is the wave of the future.

“SoftVue will allow us to detect more cancers in women with dense breasts; is operator-independent, ensuring consistent and reliable image acquisition; and offers a comfortable patient experience that is unmatched by any other imaging modality currently in the marketplace.”

Dr. Jennifer A. Harvey, chair and professor in the Department of Imaging Sciences at the University of Rochester Medical Center, adds, “As a national leading medical center in the community, we are focused on providing our patients with the best care leveraging the latest state-of-the-art technology.

“We are thrilled to be the first health care system in the region to offer SoftVue to our patients. SoftVue will allow us to detect more cancers earlier and can be performed on the same day as a patient’s mammogram, saving them time.”

Dense breast tissue (fibrous tissue that can hide cancerous lesions on a mammogram) is common, affecting 40 percent of women and making them four times more likely to develop breast cancer. Compounding the increased risk, dense breast tissue, like cancer, typically appears white on a mammogram, making it more challenging to detect cancer early.

SoftVue was developed to address the unmet clinical need for early breast cancer detection in individuals with dense breast tissue and provides a new annual screening solution for this population.

The system uses a proprietary TriAD (Triple Acoustic Detection) technology that effectively characterizes tissue by recording reflection, speed, and direction of sound waves moving through breast tissue, unlike a traditional ultrasound, which utilizes only reflection.