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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.
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November 25, 2015
12:41 EDTSIEGYSiemens to acquire Polarion, terms not disclosed
Siemens has entered into an agreement to acquire Polarion, developer of the first browser-based application lifecycle management enterprise solution, the company announced. Siemens said it will add the Polarion offerings to its Teamcenter software, which will further enhance Siemens support for systems driven product development. The transaction is expected to close during the first quarter of 2016. Terms of the acquisition will not be disclosed.
November 23, 2015
06:39 EDTSIEGYSiemens CEO: Political risk in Europe may harm investment plans, FT says
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