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# Delphinus PMA OK’d for Breast Screener
- URL: https://www.fdaweb.com/delphinus-pma-okd-for-breast-screener/
- Published: 2021-10-12T12:00:00.000Z
- Updated: 2026-09-14T17:18:44.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5150345

FDA has approved a Delphinus Medical Technologies PMA for its [SoftVue 3D Whole Breast Ultrasound Tomography System](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.delphinusmt.com%2Ftechnology%2F&esheet=52507236&newsitemid=20211012005417&lan=en-US&anchor=SoftVue%26%238482%3B+3D+Whole+Breast+Ultrasound+Tomography+System&index=2&md5=34890398b12a9cdf6787545d8b246a65&ref=fdaweb.com) for use as an adjunct to digital mammography in screening asymptomatic women with dense breast tissue. “Clinical evidence has demonstrated that SoftVue enhances dense breast screening and identifies up to 20% more cancers with greater accuracy and potentially fewer biopsies than full field digital mammography (FFDM) alone,” the company says. “The SoftVue exam is completed with no compression or radiation, and the PMA indication for use allows SoftVue exams to be performed at the same appointment as screening mammograms, facilitating a streamlined workflow and rapid delivery of results.”

The device uses the company’s proprietary [TriAD](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.delphinusmt.com%2Ftechnology%2Ftriadtm-technology%2F&esheet=52507236&newsitemid=20211012005417&lan=en-US&anchor=TriAD%26%238482%3B&index=3&md5=1921747aa42ac0a083ce910df4bef52d&ref=fdaweb.com) (Triple Acoustic Detection) technology that characterizes tissue by recording reflection, speed and direction of sound waves moving through breast tissue, unlike traditional ultrasound which only uses reflection, according to the company. It says imaging is performed with a 360-degree ring transducer that scans each breast from chest wall to nipple in about three minutes. It captures new images every two millimeters, which are then analyzed using algorithms that provide breast tissue cross-sectional slices, Delphinius says.