FDA panel OKs Hologic's Selenia 3D mammography system

September 27, 2010 by MassDevice staff

The Food & Drug Administration's Radiological Devices Panel votes in favor of pre-market approval for Hologic Inc.'s Selenia Dimensions 3D digital mammography tomosynthesis device.

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Hologic Inc.'s (NSDQ:HOLX) Selenia Dimensions 3D digital mammography tomosynthesis system edged closer to approval from the Food & Drug Administration last week.

The device 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, according to the Bedford, Mass.-based company.

The panel's vote is non-binding in terms of the device's pending application for approval, but the FDA will consider it in its final review of Hologic's PMA, according to the company.

Hologic has been waiting for approval of its Selenia Dimensions 3D system since it submitted its PMA application for the device in 2008. The system won European certification in June.

The positive vote was expected even after the company's stock dropped more than 5 percent Sept. 22 after news surfaced of possible biases appeared in the FDA's review of Hologic's clinical studies (PDF). According to the review, the device's use gave way to a 20 percent reduction in recall rates, or false diagnoses, from radiologists differentiating between cancer and non-cancer patients, but staff reviewers from the watchdog agency said the training provided to the radiologists in Hologic's study may have corrupted the results.

Ira Loss of Washington Analysis told The Boston Globe that it may now be difficult for Hologic to win insurance reimbursement for the procedure.