Hologic has received the FDA's blessing for its 3-D Selenia Dimensions digital breast tomosynthesis system. And, as Mass Device notes, the approval comes just in time for the company, which saw Q1 profits plunge 58 percent. Nearly 200,000 women will be diagnosed with breast cancer this year. And one in eight women will be diagnosed with breast cancer during their lifetime, according to the FDA.
As part of the approval process, the FDA reviewed results from two studies in which radiologists were asked to review 2-D and 3-D images from more than 300 mammography exams. In both studies, radiologists viewing both the 2-D and 3-D images obtained a seven percent improvement in their ability to distinguish between cancerous and non-cancerous cases compared with viewing 2-D images alone.
The one drawback beyond the added cost for the 3-D image is the increased radiation, according to the Boston Globe. The agency said the combination of the 2-D and 3-D images "approximately doubled the radiation dose the patient received" and "there is uncertainty for radiation risk estimates."
"We are extremely proud to be the first company to receive FDA approval of a 3-D digital mammography system and to offer women this ground-breaking , superior imaging technology," says company President and CEO Rob Cascella. "Our Dimensions 3-D takes advantage of all of the benefits of digital mammography and quite simply makes it better with the combination of fast, high quality 3-D breast imaging. We believe tomosynthesis has the potential to change how screening and diagnostic mammography is performed, and over time will prove invaluable to the earliest possible detection of breast cancer and in the reduction of unnecessary diagnostic interventions."
Hologic recently agreed to pay $125 million to acquire privately held Interlace. The company makes the MyoSure hysteroscopic tissue removal system that helps easily remove fibroids and polyps.