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FDA to review expanded approval for Hologic's breast cancer imaging systems

Wed, 08/29/2012 - 1:29pm
Mass Device

Hologic gets a date with the FDA to explore expanded indication for its already-approved 3D digital mammography systems.

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Massachusetts-based women's health devices maker Hologic (NSDQ:HOLX) has got a date with the FDA.

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.

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