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# FDA Clears Hologic Breast Biopsy System
- URL: https://www.fdaweb.com/fda-clears-hologic-breast-biopsy-system/
- Published: 2016-04-21T12:00:00.000Z
- Updated: 2026-09-14T20:56:32.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135452

> FDA has cleared a Hologic 510(k) for the Affirm prone biopsy system that offers both 2D and 3D imaging-guided breast biopsies. The device provides a larger field of view than current systems, which allows radiologists to better target lesions found during 3D mammography exams, as well as other screening modalities, according to the company. “With the patient lying prone, the biopsy system provides true 360-degree access to lesions using a fully integrated C-Arm,” it says. “Approach angles can be varied with minimal movement on the patient’s part, as the patient is supported stably throughout the procedure.”