AirXpanders Inc.'s AeroForm system for breast reconstruction was approved by the U.S. FDA.

"The market opportunity for AirXpanders in the U.S. is significant, with the total addressable market worth more than US$800 million. As U.S. mastectomy rates continue to rise and growing numbers of women undergo breast reconstruction, we are confident AeroForm will positively redefine the reconstruction process for women in the U.S.," AirXpanders President and CEO Scott Dodson said in a statement.

The system is targeted for commercial launch in the U.S. in January 2017.