FDA panel gives nod to Hologic tomosynthesis PMA

Sep 23, 2010

An advisory panel of the U.S. Food and Drug Administration today unanimously approved a premarket approval (PMA) application from Hologic 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.

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Images of a 39-year-old who underwent screening mammography. Right craniocaudal (left) and mediolateral oblique (middle) views from preoperative mammography show suspicious grouped fine pleomorphic calcifications (arrows). After biopsy showed ductal carcinoma of situ (DCIS), patient underwent breast-conserving surgery, yielding final diagnosis of ductal carcinoma in situ (intermediate grade, hormone receptor positive). (Right) Screenshot of an output of a commercial AI tool applied to preoperative mammography. AI detected right breast lesion with score of 95% on both views (concentric colored circles). Present study’s reviewing radiologist deemed AI marking to correspond with site of DCIS.
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