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Delphinus Medical Announces Installation of SoftVue Breast Imaging System at UR Medicine

March 08, 2023

Latest installation demonstrates fast-growing adoption of first-of-a-kind cancer screening technology for women with dense breasts

Delphinus Medical Technologies announced today the latest installation of its SoftVue™ 3D Whole Breast Ultrasound Tomography System since FDA approval of its advanced technology for screening women with dense breast tissue. UR Medicine is now the third medical center in the world offering dense breast cancer screening with SoftVue.

“Breast imaging radiologists are very aware of the limitations of mammography in women with dense breasts. At least 40% of US women have dense breasts. We need to do better and 3D imaging is the wave of the future”

“SoftVue addresses the critical need for an effective, comfortable breast cancer screening solution for women with dense breasts. 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,” said Mark J. Forchette, president and CEO, Delphinus Medical Technologies, Inc. “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 U.S. Food & Drug Administration (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 call-backs 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% of US women have dense breasts. We need to do better and 3D imaging is the wave of the future,” said Avice M. O’Connell, MD, FACR, FSBI, FRCPI, FAIUM, Division Head of Breast Imaging, Professor of Imaging Sciences, University of Rochester. “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.”

“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 healthcare system in the region to offer SoftVue to our patients,” said Jennifer A. Harvey, MD, Chair and Professor, Department of Imaging Sciences at University of Rochester Medical Center. “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 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 identifies more cancers, with fewer callbacks, using 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 traditional ultrasound which utilizes only reflection. In addition, SoftVue is the only ultrasound-based breast imaging system that was approved by the FDA for same day screening as mammography for this population of women.

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