FDA approval granted for new breast imaging tool developed in Detroit

SoftVue™ 3D Whole Breast Ultrasound Tomography System developed by Karmanos Cancer Institute spinoff Delphinus Medical Technologies, LLC

Karmanos Cancer Institute is pleased to celebrate the FDA approval of SoftVue™ 3D Whole Breast Ultrasound Tomography System (SoftVue™) for use as an adjunct to digital mammography in screening asymptomatic women with dense breast tissue. This technology was developed by Delphinus Medical Technologies, LLC, which originated as part of Karmanos Cancer Institute.

This unique technology helps to accurately detect many early stages of breast cancer, even in women with dense breast tissue. Mammography alone misses about half the cancers in women with dense breasts. 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.

How it works 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 Sequr™ Breast Interface 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.

Clinical evidence has demonstrated that SoftVue identifies up to 20 percent more cancers with greater accuracy than full-field digital mammography (FFDM) alone. Additionally, the SoftVue exam is completed with no compression or radiation, and exams can be performed at the same appointment as screening mammograms without the need for an extra appointment.