DETROIT – The Barbara Ann Karmanos Cancer Institute, “the Detroit-based National Cancer Institute-designated comprehensive cancer center, is the first to receive the SoftVue 3-D Whole Breast Ultrasound Tomography System following its approval by the Food and Drug Administration,” DBusiness (DB) reported on September 23.
“Developed by Novi-based Delphinus Medical Technologies, the new and advanced technology was designed to be the screening solution for women with dense breast tissue,” DB reported, adding that “this 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 typically appears as a solid white area on a mammogram, making it difficult to distinguish from masses and other serious abnormalities, missing roughly half of new cancer cases,” DB reported, noting that “when paired with a screening mammogram, SoftVue has been shown to identify up to 20 percent more cancers and increase specificity by 8 percent, while also reducing false positives and decreasing unnecessary call-backs and biopsies.”
“As a leading cancer center, we are committed to providing our patients with superior diagnostic technology and the development of SoftVue, in partnership with Delphinus Medical Technologies, will further strengthen our fight against breast cancer that accounts for one in three new cancer diagnoses in women each year,” Brian Gamble, president of the Karmanos Cancer Hospital, told DB. “The key to breast cancer survival is early detection and this new screening device will be lifesaving for so many women in our community. Our clinical team worked hard for many years to develop this transformational technology, and we are proud to be the first in the world to offer SoftVue to our patients.”
“In 2009, Karmanos launched Delphinus Medical Technologies,” DB reported, adding that “the two organizations have since worked on various prototypes and conducted dozens of clinical trials to develop the state-of-the-art technology, demonstrating its ability to detect the presence of malignant and benign masses in women with dense breasts safely and more accurately.”
“SoftVue, used as an adjunct to mammography, allows women with dense breast tissue to have both cancer screenings during a single appointment,” DB reported, noting that “taking approximately eight to 10 minutes, a SoftVue mammogram uses warm water and ultrasound technology to create a 3-D image of the whole breast to detect the presence of cancer in its earliest stages — including masses in dense breast tissue often missed by mammography alone — while avoiding radiation exposure and compression, allowing the radiologist to make a more accurate diagnosis.”
“The team at Karmanos has contributed deeply to the creation of our breakthrough SoftVue ultrasound tomography system, and we are thrilled to announce that they placed the first order in the world for our commercial system,” Mark J. Forchette, president and CEO of Delphinus, told DB. “We are excited about our next steps together to provide a new solution for the unmet needs and challenges of dense breast screening, and to share our proven clinical benefits with their patients.”
“The SoftVue system will be available to patients at Karmanos Cancer Institute in early 2023,” DB reported.
More detailed information is available online: https://www.karmanos.org/karmanos/softvue.