Hologic Receives FDA Approval for New Breast Tomosynthesis Software

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Hologic's new C-View 2D imaging software got the green light from the Food and Drug Administration, which means that C-View 2D images may now be used in place of the conventional 2D exposure previously required as part of a Hologic 3D mammography (breast tomosynthesis) screening exam.

Because the software can generate C-View images from the 3D tomosynthesis data acquired during the mammography exam, patients no longer need to endure the greater scanning time required to get the additional 2D exposures. The need for fewer images also reduces the patient’s overall radiation dose.

"Eliminating the need for additional 2D exposures will provide a better experience for patients," said Peter Soltani, Hologic Senior Vice President and General Manager, Breast Health in the press release.

Hologic is currently the only manufacturer with an FDA-approved tomosynthesis technology, but other companies are developing their own devices. Beating back new competitors will require having the most advanced and cost-effective option.

The C-View 2D imaging software has been commercially available in Europe and many countries in Latin America and Asia since 2011. In the United States, the company expects to begin shipping the C-View software as as an optional package to new and existing customers next month.