Women's imaging vendor Hologic has received clearance from the U.S. Food and Drug Administration (FDA) for its Affirm dedicated prone biopsy system.
Affirm is the first such system to offer both 2D and 3D imaging, according to Hologic. It features a larger field-of-view than other prone biopsy devices and provides 360° access to lesions using an integrated C-arm.
The system expands Hologic's breast biopsy portfolio, complementing its Genius 3D mammography system and its Affirm upright biopsy system, Hologic said. The system has already received the CE Mark.
