FDA approves Hologic's Selenia 3D mammography system

February 11, 2011 by MassDevice staff

The Food & Drug Administration approves the first three-dimensional mammography imaging system, Hologic Corp.'s Selenia.

HOLX logo

The plant inspection must have gone well, because the Food & Drug Administration approved Hologic Corp.'s (NSDQ:HOLX) one-of-a-kind 3d breast imaging platform, the Selenia, for performing mammograms.

Late last year, the federal watchdog agency told the Bedford, Mass.-based women's health firm that only an inspection of its manufacturing facilities separated the company from a long-awaited approval of the system. It incorporates 3-D imaging with 2-D imaging for breast exams to give radiologists a clearer image with more data. The device's tomosynthesis technology produces 3-D images by digitally combining multiple X-rays, alleviating the issues associated with distortion by tissue shadowing or density, according to the company.

"Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches," Center for Devices & Radiological Health chief Dr. Jeffrey Shuren said in prepared remarks.

In September, the system won unanimous favorable votes from the the agency's Radiological Devices Panel on effectiveness and safety and that the benefits of the system's technology outweigh its risks. Hologic has been waiting for approval of its the system since it submitted a pre-market approval application in 2008. The Selenia won European certification in June.

The first Selenia systems sold for tomosynthesis are likely to hit the U.S. before insurers decide how to reimburse for its use, but the platform can be used just for 2-D while Hologic waits for the final reimbursement call on 3-D screening.