Delphinus Gains 510(k) Clearance for Breast Ultrasound Tomography

January 24, 2014 — The U.S. Food and Drug Administration (FDA) gave 510(k) clearance to Delphinus Medical Technologies Inc. for its SoftVue whole breast ultrasound tomography system, approved for diagnostic breast imaging.

The SoftVue system utilizes ring transducer technology to transmit and receive ultrasound signals from around the entire breast. Examination involves suspending the breast in warm water and lasts one to two minutes per breast. The technology is a whole breast ultrasound tomography imaging device that provides no radiation, no compression and is not dependent on operator skills. 

For more information: www.delphinusmt.com