A three-dimensional imaging device to screen and diagnose breast cancer made by Hologic Inc. is one step closer to U.S. Food & Drug Administration approval.
The company announced that the FDA will formally review the new device Sept. 24 as part of the company’s effort to get the tool approved for market in the U.S. The device is already approved for use in a dozen countries in Europe and South America, as well as Canada and Mexico.
Similar screening systems made by Hologic are already used in the United States, but they only produce two dimensional images. 3D images, the company said, will produce a more accurate and complete reading for doctors. The company said breast anatomy can mask some breast cancers when viewed by a traditional 2D system.
Hologic makes medical imaging and surgical products for the female healthcare industry. The company is based in Bedford and has offices in Marlborough.
