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FDA Panel Supports Approval Of Hologic’s C-View Software For 3D Digital Mammography

PMA supplement approval endorsed by FDA’s Radiological Devices panel Oct. 24 would enable creation of 3D and 2D images from a single scan, thereby reducing radiation exposure compared to the current process.

The benefits of Hologic Inc.’s C-View software for three-dimensional digital mammography exams outweigh the risks, FDA’s Radiological Devices panel concluded in a 9-1 vote Oct. 24.

The advisory panel also voted 9-1 that C-View, which enables 3D mammography with less radiation than the current process, demonstrated...

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