Later this year the federal watchdog agency’s Radiological Devices Panel will meet in Washington D.C. to discuss expanding approval for Hologic’s 1st-of-its-kind Selenia Dimensions 3D digital mammography system.
The device, which originally won FDA approval in February 2011 after winning a unanimous panel recommendation in September 2010, incorporates 3D imaging with 2D imaging in breast exams by digitally combining multiple X-rays to help radiologists get a view unobstructed by distortion, tissue shadowing or density.
The Selenia Dimensions is currently approved for breast cancer screening and diagnosis with full-field digital mammography alone or paired with digital breast tomosynthesis. The company is eying expanded indication that includes use of its new C-View software, which generates synthetic 2D images using digital breast tomosynthesis.
The Selenia Dimensions systems played a big role in Hologic’s forecast-beating financial reports, as sales of the devices are ramping up more quickly than the company had expected.
The FDA plans to review Hologic’s expanded Selenia Dimension application on October 24, according to a notice in the Federal Register.
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