The clinical evidence has shown that SoftVue improves dense breast screening and detects up to 20% more cancers with improved accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone
Delphinus Medical Technologies has secured premarket approval (PMA) from the US Food and Drug Administration (FDA) for its SoftVue 3D whole breast ultrasound tomography system.
The approval enables to use the system as an adjunct to digital mammography to screen asymptomatic women with dense breast tissue.
According to the company, clinical evidence has shown that SoftVue improves dense breast screening and detects up to 20% more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone.
The approval allows SoftVue exam, which is completed with no compression or radiation, to be conducted at the same appointment as screening mammograms.
By using a distinctive Triple Acoustic Detection (TriAD) technology, the SoftVue system characterises tissue by recording reflection, speed and attenuation of sound waves moving through breast tissue to detect more cancers, where as traditional ultrasound uses only reflection.
A patient is made to relax on her stomach with breast submerged in a warm water bath during the exam, said the company.
A disposable Sequr Breast Interface gel pad is used to comfortably stabilise and place the breast at the centre.
With a 360-degree ring transducer, imaging is performed scanning each breast from the nipple to the chest wall in an average of three minutes to capture new images every two millimeters.
Later, the captured signals will be analysed using advanced algorithms, which offer cross-sectional slices of the complete volume of breast tissue.
Delphinus president and CEO Mark Forchette said: “Our SoftVue System delivers a breakthrough in tissue characterization 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.”
Delphinus has conducted a Prospective Case Collection (PCC) study, which served as the image database for the cancer and non-cancer cases.
The cases have been used in a series of multi-reader, multi-case (MRMC) studies carried out by the University of Chicago.