FDA Approves 3-D Breast Ultrasound Device

Yael Waknine

Disclosures

January 10, 2014

The US Food and Drug Administration has granted 510(k) clearance for a diagnostic imaging system (SoftVue, Delphinus Medical Technologies, Inc.) that uses ultrasound technology to provide accurate operator-independent 3-dimensional images of the entire breast in 1 to 2 minutes.

Patient-centric benefits include a lack of painful breast compression; women simply lie down on a comfort pad while the breast is suspended in a warm water bath, surrounded by a soft pliant membrane that accommodates all breast sizes and contours to the chest wall.

"The breast is lowered through a hole in the table so that the ring array can go all around to the chest wall, even to the axilla, and then you push a button and the entire breast is scanned in 1 to 2 minutes," Peter J. Littrup, MD, chief medical officer at Delphinus, pointed out in an interview with Medscape Medical News.

The short scan is performed by a transducer ring comprised of more than 2000 elements that emit ultrasound signals in a sequenced 360 degree circular array around the entire breast. Images are automatically acquired in 2 mm increments from the chest wall/axilla, and can be stacked "like slices of bread" for 3-D viewing or tiled for comparison with other studies.

SoftVue diagnostic imaging system

"We measure 2 new parameters that we've never had before — speed of sound and attenuation. By combining these objective quantifiable parameters, we can better characterize the type of tissue present," Neb Duric, PhD, chief technology officer at Delphinus, told Medscape Medical News.He explained that the device captures reflection echoes from all directions around the breast while gathering transmitted signals coming through the breast.

"I think this device is a promising new tool that will aid in the detection and characterization of breast abnormalities," asserted Robert Zimmerman, MD, radiation oncologist and medical director of the Santa Clarita Radiation Therapy Center in Valencia, California, in an interview with Medscape Medical News.

Dr. Zimmerman, who has no involvement with the system, has done extensive research in cancer treatment, resulting in numerous publications and presentations related to radiation oncology. He told Medscape Medical News that he discussed the system with colleagues at a meeting he recently attended, and said their initial reactions to the idea were enthusiastic.

Unlike mammography, "this device offers the ability to detect masses in woman with dense breast tissue, and is able to do so without the use of radiation. Hopefully, this will prove to be a more cost-effective methodology than an MRI of the breast. This exam is also much quicker than an MRI and does not require the use of intravenous contrast," Dr. Zimmerman added.

The groundbreaking technology is also a significant improvement on current 2-D ultrasound techniques, which are limited to reflected echoes returning in the direction of the linear transducer and reliant on operator expertise, according to the company.

"There's a lot of power in this technology," stated Mark Morsfield, chief executive officer at Delphinus, in an interview with Medscape Medical News. He added that the company plans to study the potential value of the system in reducing biopsy rates and enhancing diagnostic accuracy.

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