Selenia Dimensions is currently approved for breast cancer screening and diagnosis with full-field digital mammography alone or paired with digital breast tomosynthesis. The company is eying expanded indication that includes use of its new C-View software, which generates synthetic 2D images using digital breast tomosynthesis.
The C-View software module provides the ability to synthesize 2D images from 3D data, allowing physicians to use both in screening. The upgrade would not require any changes to the hardware of the devices.
The FDA panel earlier this week voted 9-to-1 in favor of expanding indication, deeming the new system safe and effective and deciding that the benefits of the C-View upgrade greater than the potential risks.
In documents released from the hearing, the panel detailed its conversation prior to taking a vote:
"The panel discussed the generalizability of the clinical study results in support of the proposed indication for use given the study design and specific study exclusions. The panel discussed training and labeling considerations given that the synthesized 2D images are similar, but not identical to [full field digital mammography]. The panel noted the importance of informing users that the synthesized 2D images were only to be used with the 3D images. Finally, the impact of the device on clinical practice was discussed."
There were no speakers for the "open public hearing" portion of the meeting, panelists noted.
The Selenia Dimensions system, which originally won FDA approval in February 2011 after winning a unanimous panel recommendation in September 2010, incorporates 3D imaging with 2D imaging in breast exams by digitally combining multiple X-rays to help radiologists get a view unobstructed by distortion, tissue shadowing or density.