Delphinus Medical Technologies, a Novi, Michigan-based medical imaging company, announced today that the US Food and Drug Administration has approved its pre-market breast cancer screening ultrasound machine.
The SoftVue 3D whole-breast ultrasound tomography system is intended to be used in addition to digital mammograms to screen for breast cancer in patients with dense breast tissue. The device was specially developed for screening patients with density categories c (heterogeneous dense) or d (extremely dense) of the Breast Imaging Reporting and Database System (BI-RADS).
During the exam, the patient lies on the SoftVue device with the chest immersed in a warm water bath while the device performs the scan. It uses a proprietary 360-degree ring transducer to examine each breast from the chest wall to the nipple and then analyze it for lumps. All of this happens without compression or radiation, according to the company.
Since SoftVue is specified in the premarket approval as a supplement to mammograms, it should be carried out on the same date as mammography screenings. Delphinus says this will facilitate streamlined workflows and quick implementation of results.
“Our SoftVue system delivers a breakthrough in tissue characterization and improves the ability to find cancer in dense breast patients,” said Mark Forchette, President and Chief Executive Officer of Delphinus.
“It will be a game changer that will transform clinical practice with a fundamentally new and extremely powerful approach. SoftVue PMA approval opens the door to a technological advance in dense breast screening that will help doctors save lives. “
WHY THIS IS IMPORTANT
More than 40% of 40- to 74-year-old women have heterogeneous or extremely dense breasts, they say Journal of the National Cancer Institute. Dense breasts are more common in young people and those with a lower body mass index.
The dense breast tissue not only increases the risk of breast cancer, but it also makes it difficult for radiologists to detect cancer on mammograms, according to the American Cancer Society.
The risk of dense breast tissue is so great that the FDA updated the Mammography Quality Standards Act of 1992 to require that patients be informed if they have dense breasts after mammograms.
There are other breast cancer screening tests like MRIs and ultrasound, but these methods can result in more tests, biopsies, radiation exposure, and higher costs because these tests aren’t always covered by insurance, according to the Mayo Clinic.
THE BIGGER TREND
With around 13% of women developing breast cancer at some point in their lives, screening is an important tool in identifying when it is more treatable. As such, there are a number of technology-enabled screening systems on the market today.
Volpara Health has developed a number of FDA-cleared breast cancer screening products using artificial intelligence. Most recently, it received another 510 (k) clearance for its core algorithm, Volpara Imaging Software. It also won the other breast health company, CRA Health, earlier this year.
Zebra Medical Vision also has a number of 510 (k) approvals for its HealthMammo platform. It got its last release last year to help radiologists identify suspicious mammograms.
Whiterabbit is a newer player in space, and earlier this year it emerged from the stealth with a 510 (k) clearance in hand.
Even Google has developed artificial intelligence for breast cancer screening that improves the accuracy of cancer detection.