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


Related Content

News | RSNA

July 23, 2024 — Professional registration is open for RSNA 2024, the world’s largest radiology forum. This year’s theme ...

Time July 23, 2024
arrow
News | Artificial Intelligence

July 23, 2024 — Researchers at the National Institutes of Health (NIH) found that an artificial intelligence (AI) model ...

Time July 23, 2024
arrow
News | Artificial Intelligence

July 22, 2024 — Healthcare artificial intelligence (AI) systems provider, Qure.ai, has announced its receipt of a Class ...

Time July 22, 2024
arrow
News | Radiology Business

July 19, 2024 — GE HealthCare announced it has entered into an agreement to acquire Intelligent Ultrasound Group PLC’s ...

Time July 19, 2024
arrow
News | Radiology Education

July 19, 2024 — Core tactics to address the current medical imaging and radiation therapy workforce shortage and build ...

Time July 19, 2024
arrow
News | Computed Tomography (CT)

July 18, 2024 — NeuroLogica Corp, a subsidiary of Samsung Electronics Co. Ltd., announced its latest configuration of ...

Time July 18, 2024
arrow
News | Digital Radiography (DR)

July 18, 2024 — At the Annual Meeting of AHRA (the Association for Medical Imaging Management), Agfa Radiology Solutions ...

Time July 18, 2024
arrow
News | Flat Panel Displays

July 17, 2024 — LG Electronics (LG) is accelerating its B2B medical device business, expanding its lineup of diagnostic ...

Time July 17, 2024
arrow
News | Artificial Intelligence

July 17, 2024 — Hyperfine, a groundbreaking medical device company that has redefined brain imaging with the world’s ...

Time July 17, 2024
arrow
News | Magnetic Resonance Imaging (MRI)

July 16, 2024 — Fujifilm Healthcare Americas Corporation, a leading provider of diagnostic and enterprise imaging ...

Time July 16, 2024
arrow
Subscribe Now