Delphinus wins FDA approval for breast ultrasound exam system

NOVI—Officials at Delphinus Medical Technologies Inc. announced that the U.S. Food and Drug Administration has granted premarket approval of its SoftVue 3D Whole Breast Ultrasound Tomography System.

The system is indicated for use as an adjunct to digital mammography in the screening of asymptomatic women with dense breast tissue. Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20 percent more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone.

The SoftVue examination procedure. Delphinus Medical Technologies photo.

The SoftVue exam is completed with no compression or radiation, and the indication for use allows SoftVue exams to be performed at the same appointment as screening mammograms, facilitating a streamlined workflow and rapid delivery of results. The system uses 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.

“SoftVue plus mammography finds more cancers when screening women with dense breasts,” said Delphinus board member Rachel Brem, director for breast imaging at George Washington University Hospital in Washington, D.C. “The FDA clearance for same day imaging optimizes workflow while providing unparalleled patient comfort with no compression or radiation, will make patient screening more comprehensive, efficient and effective. It is exciting to have a new cutting-edge technology that detects more cancers and does so with fewer biopsies.”

SoftVue was developed to address the unmet clinical needs for early breast cancer detection in individuals with dense breast tissue—fibrous tissue that can hide cancerous lesions on mammogram—and provides a new annual screening solution for this population. During the exam, the patient relaxes on her stomach with her breast submerged in a warm water bath. The breast is comfortably stabilized and centered with a disposable gel pad. Imaging is performed with a proprietary 360-degree ring transducer, scanning each breast from chest wall to nipple in an average of three minutes, capturing new images every two millimeters. The captured signals are then analyzed using sophisticated algorithms that provide cross-sectional slices of the entire volume of breast tissue.

“Our SoftVue System delivers a breakthrough in tissue characterization and improves the ability to find cancers in dense breast patients,” said Mark J. Forchette, president and CEO at Delphinus. “It will be a game changer that will transform clinical practice with a fundamentally new, and highly impactful approach. The SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”

Mammography alone misses about half the cancers in women with dense breasts. The lower sensitivity of mammography in women with dense breast tissue coupled with their substantially increased risk of breast cancer clearly demonstrates the need for additional screening approaches to detect cancers that mammograms can’t find. Those with Breast Imaging Reporting and Database System (BI-RADS) density categories c (heterogeneously dense) and d (extremely dense) have a four-fold increased risk for developing breast cancer. Forty percent of women in the U.S. have dense breast tissue, so that increased risk, combined with decreased sensitivity, creates a significant challenge for this population. It has become such an obvious public health issue that there is now a federal mandate to inform women if they have dense breasts after every mammogram.

Delphinus executed a Prospective Case Collection (PCC) study that served as the image database for the cancer and non-cancer cases that were subsequently used in a series of multi-reader, multi-case (MRMC) studies conducted by the University of Chicago. The PCC initiative began in 2017 and ultimately enrolled more than 8,500 asymptomatic patients in c or d density categories at 10 leading breast imaging centers around the US. A team of radiologists analyzed more than three million coronal plane images generated by the initiative.

The studies demonstrated that SoftVue detects and distinguishes between normal (BI-RADS 1 and 2) and abnormal (BI-RADS 3 and 4) lesions with an increase in both sensitivity of 20% and specificity of 8%, as compared to FFDM alone. Additionally, 95% of patients surveyed after their SoftVue exam indicated that they would recommend SoftVue to other women.

“With the FDA approval of SoftVue, we now have a critical new imaging tool for screening women with dense breasts to enable the earlier detection of breast cancer,” said Mary Yamashita, lead investigator of the SoftVue clinical trial and Clinical Associate Professor of Radiology at Keck School of Medicine, University of Southern California, Los Angeles. “We have immense gratitude for the patients and their families, clinicians and technologists that worked so hard to make this rigorous study a success. We have expanded the tools available for breast cancer diagnosis, particularly in a population of women most in need of this technology.”

To learn more about the SoftVue 3D Whole Breast Ultrasound Tomography system, visit

Delphinus was founded as a spin out of the Karmanos Cancer Institute in Detroit and is capitalized through principal investments by Arboretum Ventures, Ann Arbor; Beringea, Farmington Hills; the State of Michigan Retirement System; North Coast Technology Investors, Ann Arbor; Venture Investors, Madison, Wis.; Hopen Life Science Ventures, Grand Rapids; and Waycross Ventures, Menlo Park, Calif.

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