Premarket FDA Approval for Delphinus 3D Whole-Breast Ultrasound System

Delphinus’ new 3D whole-breast ultrasound system for detecting cancer in women with dense breasts has gotten U.S. Food and Drug Administration approval, according to Amerigo Allegretto of

“The company’s SoftVue 3D whole-breast ultrasound tomography system is intended as an assist to digital mammography for screening asymptomatic women with dense tissue,” according to Allegretto.

“‘[FDA approval] is a huge validation of our hard work and the uniqueness of the system,’ CEO Mark Forchette told,” quotes Allegretto.

Allegretto describes the process and advantages thusly:

“During a SoftVue exam, the woman lies on her stomach with her breasts submerged in a warm-water bath. After the breasts are stabilized and centered with a disposable gel pad, the device scans each breast from chest wall to nipple tip in an average of three minutes. The exam is performed with a 360° ring transducer and captures new images every 2 mm. The technology captures the reflection, speed, and attenuation of sound waves as they pass through tissue, which helps distinguish normal from abnormal lesions, the company said. The signals are analyzed using algorithms that provide cross-sectional slices of the entire volume of breast tissue.

“With the FDA’s premarket approval, SoftVue exams can be performed at the same appointment as screening mammograms.”


Allegretto, Amerigo. Delphinus gets FDA nod for 3D whole-breast US system. October 12, 2021, at Accessed October 25, 2021.

Breast ultrasound stock photo. Not a depiction of the image obtained by the Delphinus system.