FDA’s Panel Recommends Approval Of Hologic’s Selenia 3D Mammography system

Hologic, a major company providing digital mammography systems, announced that the Radiological Devices Panel of the FDA has recommended approval for its Selenia Dimensions 3D digital mammography tomosynthesis system. However, the Panel’s recommendation is not obligatory. The Panel recommended the approval following the evaluation of Selenia 3D system’s safety and effectiveness for early detection of breast cancer.The Co‐Founder and Chief Technical Officer of Hologic, Jay A. Stein, commented “Our Selenia Dimensions 3D 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”