Bedford-based Hologic Inc. has received a U.S. Food and Drug Administration approval letter regarding its 3-D digital mammography system.
Hologic is a medical device company that focuses on women’s health. It has operations in Marlborough.
The company’s Selenia Dimensions mammography system is already approved for use in Europe, Latin America and Asia.
Before final approval, Hologic’s manufacturing facility and methods will be inspected by the FDA.
