Delphinus Gains Premarket Approval for Breast Ultrasound Tomography System

Delphinus Medical Technologies has received the FDA’s premarket approval for its SoftVue 3D whole breast ultrasound tomography system as an adjunct to digital mammography to screen asymptomatic women with dense breast tissue.

The company developed SoftVue to address an unmet clinical need for early breast cancer detection in individuals with dense breast tissue — fibrous tissue that can hide cancerous lesions on mammogram scans.

The system can identify more cancers using its proprietary triple acoustic detection technology that analyzes tissue by recording reflection, speed and attenuation of sound waves, the company said.