Breast cancer: FDA panel votes to expand PMA for Hologic's mammography system

October 26, 2012 by MassDevice staff

The FDA's Radiological Devices Panel votes to approve expanded indication for Hologic's Selenia 3D digital mammography system.

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The FDA's Radiological Devices Panel this week voted to grant Hologic's (NSDQ:HOLX) expanded approval for its 1st-of-its-kind Selenia Dimensions 3D digital mammography system.

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.

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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: