FDA eases rules on digital mammography devices

Nov 3, 2010

The U.S. Food and Drug Administration has downgraded the classification of full-field digital mammography devices from high risk to medium risk, making it easier for companies to bring the technology to market, the agency announced today.

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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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