The US Food and Drug Administration (FDA) has granted premarket approval (PMA) to Delphinus Medical Technologies’ SoftVue 3D Whole Breast Ultrasound Tomography System.

Indicated for use as an adjunct to digital mammography, the system helps to screen asymptomatic women with dense breast tissue for cancer.

Dense breast tissue is fibrous tissue that can conceal cancerous lesions in mammogram scans.

The company developed the system to address the unmet clinical need of identifying early breast cancer in people that have dense breast tissue.

Leveraging triple acoustic detection (TriAD) technology, the system can detect more cancers with fewer callbacks, according to the company

Standard ultrasound uses the reflection of sound waves, while this new technology distinguishes tissues by capturing reflection, speed and attenuation of sound waves passing through the breast tissue.

Imaging is done with the help of a 360-degree ring transducer, which scans each breast in nearly three minutes and takes images for every two millimetres.

Using complex algorithms that offer cross-sectional slices of the complete breast tissue volume, such captured signals are then subsequently assessed.

The company stated that the clinical evidence has shown SoftVue to boost dense breast screening, with detection of up to 20% more cancers with higher precision and fewer biopsies as against full-field digital mammography (FFDM).

Furthermore, the examination using SoftVue does not require compression or radiation.

Delphinus president and CEO Mark Forchette said: “Our SoftVue System delivers a breakthrough in tissue characterisation and improves the ability to find cancers in dense breast patients.

“It will be a game changer that will transform clinical practice with a fundamentally new, and highly impactful approach.

“The SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help physicians save lives.”

In March 2020, a study found that Delphinus’ whole breast ultrasound tomography (UST) may provide more reliable information about breast cancer risk compared to mammography.