SoftVue Cancer Screening For Dense Breasts


15 Nov 2023 | 0 | by kjh

2568570login-checkSoftVue Cancer Screening For Dense Breasts

The FDA has issued a national requirement for dense breast reporting to patients and their referring providers effective September 10, 2024.  That means that you will be notified if you have dense breasts or not.  If you do have dense breasts, your doctor should let you know that dense tissue makes it harder to find breast cancer on a mammogram and it also raises the risk of developing breast cancer. You should be made aware of other imaging tests in addition to a mammogram to help find cancer.  Currently there are states that require some level of breast density notification but there is no national standard regarding notification to individual patients. The new law will change that.

For women with dense breasts, mammography alone is not sufficient. It is estimated that more than 40% of women in the U.S. have dense breast tissue. One company called Delphinus Medical Technologies has developed a 3D whole breast ultrasound that allows women to lie facedown on the exam table.  The technology, called SoftVue, is approved for diagnostic screening and it generates tomographic image volumes of the entire breast. 

Using sound, water and ring transducer, each breast is scanned discreetly in 2-3 minutes. During the exam, one breast at a time is immersed in warm water, then the ring transducer emits soundwaves as it moves up the breast collecting image data every 2mm. The breast is not openly seen during the scanning process and there is no compression and no radiation. SoftVue is PMA approved by the FDA indicated for dense breast cancer screening as an adjunct to mammography. SoftVue is covered under existing insurance codes; CPT 76641.

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