Delphinus Medical Technologies, a Novi, Michigan-based medical imaging company, today announced the U.S. Food and Drug Administration has given its breast cancer-screening ultrasound device premarket approval.

The SoftVue 3D Whole Breast Ultrasound Tomography System is intended to be used in addition to digital mammograms to screen for breast cancer among patients with dense breast tissue. Specifically, the device is designed for screening patients with Breast Imaging Reporting and Database System (BI-RADS) density categories of c (heterogeneously dense) or d (extremely dense).

During the exam, the patient lays on top of the SoftVue machine with their breast submerged in a warm water bath while the machine conducts the scan. It uses a proprietary 360-degree ring transducer to examine each breast from the chest wall to the nipple to then be analyzed for lumps. All of this is done without compression or radiation, the company said.

Because the premarket approval indicates SoftVue as an adjunct to mammograms, it is intended to be performed at the same appointment as screening mammograms. Delphinus says this will facilitate streamlined workflows and a quick turnaround for results.

“Our SoftVue System delivers a breakthrough in tissue characterization and improves the ability to find cancers in dense breast patients,” Mark Forchette, president and chief executive officer at Delphinus, said in a statement.

“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.”

WHY THIS MATTERS

More than 40% of women aged 40 to 74 years old have heterogeneously or extremely dense breasts, according to the Journal of the National Cancer Institute. Having dense breasts is more common among young people and those with lower body mass indexes.

Not only does having dense breast tissue put people at higher risk for breast cancer, it also makes it more difficult for radiologists to see cancer on mammograms, according to the American Cancer Society.

The risk of having dense breast tissue is so significant that the FDA has updated the Mammography Quality Standards Act of 1992 to mandate that patients be informed if they have dense breasts after mammograms.

There are other breast cancer screening tests, such as MRIs and ultrasounds, but these methods can lead to more tests, biopsies, exposure to radiation and higher costs, since these tests aren’t always covered by insurance, according to the Mayo Clinic.

THE LARGER TREND

Since about 13% of women will develop breast cancer during their lifetime, screening is an important tool to catch it when it’s more treatable. As such, there are a number of tech-enabled screening systems on the market today.

Volpara Health has developed a number of FDA-cleared artificial intelligence breast-cancer-screening products. Most recently, it got another 510(k) clearance for its core algorithm, the Volpara Imaging Software. It also scooped up fellow breast health company CRA Health earlier this year.

Zebra Medical Vision also has a slew of 510(k) clearances for its HealthMammo platform. It picked up its latest clearance last year to help radiologists identify suspicious mammograms.

Whiterabbit is a newer player in the space, and earlier this year it emerged from stealth with a 510(k) clearance in hand.

Even Google has developed artificial intelligence for breast cancer screening, which was found to improve the accuracy of cancer detection.