The device's benefits outweigh the risks, including greater exposure to radiation, the Panel also voted.
Jay A. Stein, Co‐Founder and Chief Technical Officer of Hologic, said:
Our Selenia Dimensions 3‐D technology marks tremendous progress in the early diagnosis of breast cancer. The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality.
Unlike current mammography systems which only produce a two-dimensional image, the Selenia Dimensions 3‐D digital mammography tomosynthesis system generates a 3-dimensional one.
A multicenter clinical trial showed that the new device has the potential to reduce recall rates and improve cancer detection, the company wrote.
The Selenia Dimensions 3‐D digital mammography tomosynthesis system has already been approved in Asia, Europe and Latin America. When this new device is approved in the USA, current Selenia 2-Dimensional systems can be upgraded to do breast tomosynthesis (3‐D) imaging.
Hologic's President and CEO,Rob Cascella, said:
We are extremely pleased with the outcome of today's FDA Panel meeting. Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2‐D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection ‐ fast, high‐quality 2‐D and 3‐D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives.
The FDA has voiced concerns regarding patient radiation exposure from diagnostic devices. This new device can subject women to more radiation.
What is a mammogram?
A mammogram is an X-ray of the breast. The breast is placed on a device which compresses and flattens it. Mammograms can be used for either screening or diagnostics. A screening mammogram - the majority of mammograms are screening ones. It aims to determine whether a woman has any signs of breast cancer - this currently involves two X-rays of each breast. The aim is to detect whether there is a tumor which cannot be felt by touch alone.A diagnostic mammogram takes longer to do and usually exposes the woman to more radiation. They are done for three main reasons:
- When a previous screening mammogram detected an abnormality or something suspicious
- When a subjective or objective abnormality has been detected, such as pain, thickening nipple discharge, unexplained alterations in breast shape/size, or a lump.
- Special circumstances, such as when the woman has already had a breast implant, making it harder to get a good screening mammogram X-ray picture.
