The US Food and Drug Administration's (FDA) Radiological Devices Panel has voted that Hologic's Pre-Market Approval (PMA) demonstrated both the effectiveness and safety of the Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system.
The Selenia Dimensions 3-D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis which generates a three-dimensional image unlike current mammography systems.
Hologic said that the multicenter clinical study, when compared to 2-D digital mammography alone, has demonstrated that 3-D digital tomosynthesis used in combination with 2-D digital mammography has the potential to reduce recall rates and improve cancer detection.
Hologic plans to work for the approval of the Selenia Dimensions 3-D system following the FDA Panel meeting held in Gaithersburg, Maryland.
Hologic president and CEO Rob Cascella said that they are extremely pleased with the outcome of FDA Panel meeting and 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,” Cascella said.