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News Breaks
June 26, 2014
13:41 EDTSIEGYSiemens files PMA for digital breast tomosynthesis
Siemens Healthcare has announced that it recently submitted to the U.S. Food and Drug Administration its premarket approval application for the MAMMOMAT Inspiration with Breast Tomosynthesis option. In this PMA submission, Siemens Healthcare has provided the FDA with clinical study results and manufacturing information. The Siemens Breast Tomosynthesis option has been designed as an add-on option for the MAMMOMAT Inspiration digital mammography system. The Siemens Breast Tomosynthesis option has been commercially available and used clinically for diagnosis since 2009 in Europe, Asia, and South America. In the U.S., the FDA classifies breast tomosynthesis as Class III, meaning that data from a clinical trial is required to measure safety and effectiveness. Class III devices require a PMA submission to the FDA for approval.
News For SIEGY From The Last 14 Days
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July 29, 2015
06:26 EDTSIEGYSiemens, Bombardier in talks over possible train, rail merger, WSJ reports
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July 22, 2015
09:41 EDTSIEGYEnzo Biochem reaches patent infringement settlement with Siemens Healthcare
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July 20, 2015
19:22 EDTSIEGYPemex paid $295M to settle Siemens dispute, Reuters says
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