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.
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.
Hologic is also still dealing with its recent $3.7 billion buyout of molecular diagnostics giant Gen-Probe (NSDQ:GPRO). That deal preceded layoffs at one of Hologic’s manufacturing facilities.
The FDA plans to review Hologic’s expanded Selenia Dimension application on October 24, according to a notice in the Federal Register.
