Hologic Inc. (NSDQ:HOLX) announced that its Selenia Dimensions, a 3D digital mammography tomosynthesis system, will be reviewed by the Food & Drug Administration’s Radiological Devices panel.
The review, slated to take place on Sept. 24, is one of the last steps in the device’s pre-market approval application.
Bedford, Mass.-based Hologic‘s two-year-old PMA application is for clinical approval of the Selenia Dimensions system for both screening and diagnostics, the company said. The new breast-screening system’s ability to do 3D imaging sets it apart from other breast cancer detection systems, it said.
In the U.S., Selenia is only available as a 2D system that’s upgradeable to 3D tomosynthesis imaging if the product is approved by the FDA. Selenia Dimensions is available in about a dozen countries, according to the company.
The system won European certification in June.