Hologic, a developer, manufacturer and supplier of premium diagnostics products, has received an approvable letter from the US Food and Drug Administration (FDA) for its Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system.
Hologic’s Selenia Dimensions 3-D digital mammography system is a new method for breast cancer screening and diagnosis.
Unlike prior-generation mammography systems which generate two-dimensional images, breast tomosynthesis produces three-dimensional images which are intended to reveal the inner architecture of the breast, free from the distortion typically caused by tissue shadowing or density, Hologic said.
The final approval of the company’s pre-market approval application for the system remains subject to satisfactory review and inspection of their manufacturing facility, methods and controls.
Hologic president and CEO Rob Cascella said that the Selenia Dimensions technology is designed to provide radiologists with enhanced screening and diagnostic capabilities through the incorporation of fast, high-quality 3-D imaging in combination with 2-D imaging.
"We believe this new technology will address many of the limitations present in stand-alone 2-D imaging and improve upon both sensitivity and specificity. We look forward to work with the FDA to complete the remaining steps in the approval process," Cascella said.
Hologic’s Selenia Dimensions 3-D digital mammography system is a new method for breast cancer screening and diagnosis.