Karmanos Cancer Institute to receive first FDA-approved SoftVue system

New technology helps improve screening for dense breast tissue

Forty percent of women have dense breast tissue, putting them at higher risk for breast cancer and making the disease more difficult to detect with a mammogram. A new technology called the SoftVue 3D Whole Breast Ultrasound Technology System can improve screenings for those women. The first FDA-approved unit will be delivered to Karmanos Cancer Institute in just days.

NOVI, Mich. – At Delphinus Medical Technologies in Novi, Michigan, there’s excitement in the air.

“We’re super passionate about this project and to finally get it to this point is really exciting,” said Delphinus president and CEO Mark Forchette.

Forty percent of women have dense breast tissue, putting them at higher risk for breast cancer and making the disease more difficult to detect with a mammogram.

A new technology called the SoftVue 3D Whole Breast Ultrasound Technology System can improve screenings for those women. The first FDA-approved unit will be delivered to Karmanos Cancer Institute in just days.

“First and foremost, we did this because we want to save lives and find cancer for patients with dense breasts. It’s a huge issue for those patients,” said Forchette. “When the first system goes into a site, we start saving lives.”

With a SoftVue scan, the patient lies chest down in a pool of warm water while ultrasound creates a detailed image of the breast tissue. There’s no compression and no radiation. It’s used in addition to a mammogram for women with dense breasts.

“Dense breasts or breast tissue looks white on a mammogram,” said Dr. Natasha Robinette, clinical services chief of imaging at Karmanos. “Cancer also looks white on a mammogram. So if you have dense breasts, there is a higher likelihood that a cancer could be missed. SoftVue in conjunction with digital mammogram detects 20% more. So that means 20% more women are going to have their cancers detected earlier than would have what would have been just digital mammogram only.”

The technology was the brainchild of two Karmanos doctors.

“They sort of scribbled this on a napkin in about 1999,”Forchette said .

Since then, Delphinus and Karmanos have worked on prototypes and conducted dozens of clinical trials to win FDA approval last year.

It’s a long journey that’s appreciated by Vivian Linke, a Karmanos employee and an 18-year breast cancer survivor from Macomb.

“If they had had this technology, even when I found my breast cancer, it probably could have detected it a lot sooner,” said Linke. “That’s what it’s all about -- to find it early.”

While Karmanos is receiving the first unit, Forchette hopes the technology will soon be widely available.

“That’s really our objective,” Forchette said. “We want to make it as rapidly as possible available to women so that they just have a short drive to their health care provider be able to get this and so that can’t happen quick enough. It’s really exciting that it goes here first, and then it’ll expand all over the world. I think this is going to save ultimately hundreds and hundreds of thousands of lives.”

SoftVue is covered by insurance, but some women may have a co-pay.

To learn more about SoftVue or to request an appointment, click here.