Medical Innovations that will Transform Early Detection of Breast Cancer

SoftVueTM Exam Process

Subtle recessed lighting contours the SoftVue™ system, with a rainbow of selectable colors to match décor and mood, while an integrated footstep and softly-curved arches for hand placements offer a secure and easy approach.  SoftVue™ features a padded table-top allowing for comfort during the exam.

SoftVue™ has received FDA clearance for diagnostic imaging purposes and is not intended for use as a replacement for screening mammography.

 

Step One – The technologist assists the woman onto the table and helps position her on her stomach.

Step Two – Once on her stomach, one breast is suspended into a warm water reservoir.

Step Three – A soft gel guide, the Sequr™ Breast Interface, engages with the front of the breast to center, shape and steady it during the procedure.

Step Four – The volumetric ring transducer encircles the breast, imaging from the nipple to the chest wall in 2 millimeter intervals.

Step Five – Three distinct imaging volumes are created showing reflection, speed of sound, and attenuation.

 

 

Trifecta of Sound

Introducing a singularly unique approach in transducer design, SoftVue™ incorporates over 2000 transducer elements within a uniform ring configuration featuring TriAD™ triple acoustic detection. This remarkable imaging capability gathers not only reflected echoes, but quantifies the signals transmitted through the breast. The tomographic coronal image presentation delivers an unrivaled view of the structure of breast tissue, and depicts tissue attributes of sound speed and attenuation that can assist physicians in distinguishing normal tissue from areas of concern.

  • Each transducer element emits and receives ultrasound signals in a sequenced 360° circular array surrounding the entire breast, scanning automatically from the nipple to the chest wall
  • Image acquisition is conducted in 2mm increments as the transducer moves along the breast
  • TriAD™ technology captures not only reflection echoes that define anatomic detail, but also the transmission signals passing through the tissue, quantifying sound speed and attenuation
  • A coronal cross-section image set is presented of the entire breast, displayed in three volumetric image stacks for interpretation and comparison with other breast imaging studies

 

 

Reflection                                                Sound Speed                                       Attenuation

 

 

Gentle Guidance

The Sequr™ Breast Interface is a central component of the SoftVue™ system and serves an essential function. This soft anatomically-formed guide engages with the front of the breast to center, shape and steady it during the imaging procedure. By adjusting the breast contour and stabilizing the breast tissue, this one-per-patient consumable assists with proper positioning of the breast and promotes efficiency during image acquisition.

 

 

 

 


Your Health, Our Priority

Over 40% of females in the U.S. have dense breast tissue leaving a large percentage of women at a disadvantage when it comes to breast cancer screening and detection.

 

Dense Breast Tissue Imaging

It is now widely understood that mammography alone is not sufficient to detect breast cancer for women with dense breasts.

Mammography demonstrates variances in the attenuation of x-radiation as it passes through tissue. The challenge with dense breast tissue is that it can have similar attenuating properties as cancer, so a sufficient level of variance may not be appreciated by mammography, particularly problematic in the dense breast. Unlike mammography, SoftVue™ is not confounded by breast density and can find masses apart from the dense tissue based on differing acoustic properties.

 Women who have dense breast tissue have a higher risk of breast cancer compared to women with less dense breast tissue. In fact, high breast density is a greater risk factor than having two first degree relatives with breast cancer. 

Gentler Option

As a 3D whole breast ultrasound system, SoftVue™ brings a safer and softer imaging solution, introducing a new approach to imaging the entire breast using sound and water. The exam is private and discreet, the breast is not openly seen during the scanning process and there is no compression and no radiation.

At Delphinus, we are working to assist physicians gain accurate information to better detect breast cancer where it can be the most challenging, in dense breast tissue. While developing better imaging science, we are striving for a better breast imaging experience for women. SoftVue has received FDA clearance for diagnostic imaging purposes and is not intended for use as a replacement for screening mammography.

 

softvue-system


New Breast Cancer Screening Technology Being Investigated by Radiology Associates of the Fox Valley

Standard mammography has made a significant impact in the early detection of breast cancer. However, it does not serve all women equally. Finding cancers in women with dense breast can be difficult using mammography alone. Cancer and dense breast tissue both appear white using x-ray technology, which means that cancers can be hidden within dense breast tissue on mammograms. In addition, almost half of women say they do not get regular screening mammograms due to discomfort and radiation. This indicates there are challenges to overcome with standard mammography.

To address these challenges, Delphinus Medical Technologies, Inc. invented SoftVue™, a 3D whole breast ultrasound system. SoftVue™ introduces a new approach to imaging the entire breast using sound and water. Using a 360-degree imaging ring that transmits soundwaves, SoftVue™ scans the entire breast while it is immersed in warm water to create full-volumetric images of the breast. Ultrasound is not confounded by breast density, unlike mammography, which allows doctors to see cancers that may have been hidden on standard mammography. In addition, the exam is comfortable as there is no compression or radiation. Women simply lie on their stomachs with one breast at a time submerged in water. The imaging ring scans from the nipple to the chest wall without making contact with the breast to generate a full image of the breast.

Delphinus Medical Technologies, Inc. is sponsoring a large, nationwide project investigating the SoftVue™ system’s ability to detect cancer in women with dense breasts. The Radiology Associates of the Fox Valley, in partnership with the Living Well Foundation and St Elizabeth Hospital, part of Ascension, is one of eight sites across the nation participating in this research project. The goal of the project is to enroll 10,000 women with dense breasts to receive a SoftVue™ exam in order to evaluate the effectiveness of finding cancers using SoftVue™ compared to mammography.  To learn more about the SoftVue™ technology visit delphinusmt.com . To learn more about the nationwide research project visit discoversoftvue.com. 

 

Calming environment

3D Whole Breast Ultrasound System , SoftVue

Women simply lie on their stomachs with one breast at a time submerged in water

Using a 360-degree imaging ring that transmits soundwaves