Hologic is on the brink of realizing its ambition to pioneer the commercial use of 3D mammography in the U.S. The company, which for 25 years has focused on women's health, announced this morning receipt of an approvable letter from the FDA for its Selenia Dimensions digital mammography tomosynthesis system.
All that remains before this system can be marketed in the U.S. is a positive review and inspection by the FDA of the manufacturing facility, methods, and controls that Hologic has put in place to make the tomosynthesis product. The firm plans to schedule this inspection in the coming weeks. After that, it's up to the FDA.