An advisory panel of the U.S. Food and Drug Administration (FDA) today unanimously approved a premarket approval (PMA) application from Hologic of Bedford, MA, for a digital breast tomosynthesis (DBT) system. If the FDA signs off on the final PMA, Hologic will be the first vendor to sell a DBT system on the U.S. market.
The radiological devices panel of the FDA's Medical Devices Advisory Committee voted unanimously on September 23 that Hologic demonstrated both the safety and effectiveness of its Selenia Dimensions 3D digital tomosynthesis system. The panel also voted that the benefits of the system outweigh the risks.
The PMA for Selenia Dimensions now goes to the FDA, which can either accept or reject the panel's recommendation. The panel nod is a major step forward for the company, however, which conducted three clinical trials to support the PMA application.
DBT systems use a full-field digital mammography unit with a moving x-ray tube head that collects multiple projections as it pans across the breast. DBT proponents believe the technology will improve the accuracy of mammography and reduce recall rates by enabling breast imagers to see around structures that might have obscured pathology on standard 2D mammography.
Hologic's own data submitted in support of the PMA indicated that DBT had a statistically significant impact on sensitivity compared to 2D mammography. The technology also reduced the recall rate for patients who did not have cancer.
Hologic is already selling Selenia Dimensions for DBT in Europe, Latin America, and Asia, but U.S. commercialization has been awaiting FDA approval. Other mammography vendors are also developing their own versions of DBT technology.
"We are extremely pleased with the outcome of today's FDA panel meeting," said Rob Cascella, Hologic president and CEO. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologist to help save more women's lives."
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