August 24, 2012 — On October 24, 2012, the U.S. Food and Drug Administration's Radiological Devices Panel of the Medical Devices Advisory Committee will discuss, make recommendations and vote on a premarket approval (PMA) application supplement to expand the indications for use of the Selenia Dimensions 3-D system with C-View software module, sponsored by Hologic Inc.
The Selenia Dimensions 3-D system is currently approved for breast cancer screening and diagnosis. The screening exam can consist of full-field digital mammography (FFDM) alone or the combination of FFDM with digital breast tomosynthesis (DBT). The new C-View software module can generate synthetic 2-D images from the DBT data. Hologic requests to expand the indications for use to allow the combination of DBT with synthetic 2-D images to be used as another exam option for breast cancer screening.
FDA intends to make background material available to the public no later than two business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's website after the meeting. Background material is available at www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Interested persons may present data, information or views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before October 15, 2012. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 5, 2012.
Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 9, 2012.
For more information: www.hologic.com