The U.S. Food and Drug Administration approved a device that takes mammograms that will produce both two-dimensional and three-dimensional images to help medical care providers in screening for and diagnosing breast cancer.
The device the SenoClaire was approved by the U.S. regulatory agency with restrictions the FDA placed to offer a reasonable assurance of the safety and efficiency of the new mammogram device.
The FDA announced that the device has hardware and software upgrades to another device known as the Senographe Essential 2D that is already approved for mammography.
The upgrades in software applies x-ray images that are low-dose to end up with tomosynthesis or cross sectional breast view, while the new hardware creates a number of low-dose projection images in x-rays of the breasts.
While producing images that are 2D and 3D the new mammogram device can also be used for same clinical applications as the traditional mammography for screening of mammography.
Tomosynthesis images, according to the U.S. FDA will provide more information for the physicians in the detecting and the diagnosing of breast cancer.
Morris reminded GE further that the continued approval of the PMA for the mammogram device is dependent on the company submitting periodic reports that are required by the CFR21 section 814.84 that have intervals of just one-year unless it is otherwise required.
The company has to also submit an additional supplement to the PMA or a notice of 30 days to the FDA, prior to conducting a change to the mammogram devices for the purposes of efficiency and safety.
The PMA by GE was filed for the SenoClaire mammogram machine in July of 2013 and was amended in September as well as October of 2013 and again in January and April of 2014.
Breast cancer is a deadly disease that is attacking more women each year. Speak with your medical care provider regarding the use of the newly approval machine by GE.
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