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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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August 20, 2014
10:04 EDTSIEGYOn The Fly: Analyst Upgrade Summary
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August 19, 2014
19:26 EDTSIEGYSiemens upgraded to Buy from Neutral at Goldman
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August 8, 2014
08:12 EDTSIEGYLeerink healthcare technology analyst holds analyst/industry conference call
Healthcare Technology Analyst Larsen discusses Cerner's acquisition of Siemens on an Analyst/Industry conference call. Relevant companies ATHN, CPSI, MCK, QSII, VCRA also may be discussed on the Analyst/Industry conference call to be held on August 11 at 10 am.
August 7, 2014
17:57 EDTSIEGYDresser-Rand receives takeover interest, hires adviser, Bloomberg reports
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07:57 EDTSIEGYForeign trade group warns inversion crackdown could prompt job cuts, WSJ says
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