Hologic Announces FDA Nod, Commercial Launch Of Affirm Prone Biopsy System

(RTTNews) - Hologic, Inc. (HOLX), a maker of diagnostic and surgical products, announced the U.S. Food and Drug Administration or FDA clearance and commercial launch of the Affirm prone biopsy system, the first dedicated prone biopsy system to offer both 2D and 3D imaging-guided breast biopsies. The system is now available for order in the U.S.

With a larger field of view than existing dedicated prone biopsy systems, the new Affirm prone biopsy system allows radiologists to better target lesions found during 3D mammography exams, as well as other screening modalities. Furthermore, this new product features a streamlined workflow with increased automation designed to make using the system fast and easy.

With the patient lying prone, the biopsy system provides true 360-degree access to lesions using a fully integrated C-Arm.

Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions said, "The launch of our Affirm prone biopsy system is the most significant advancement in prone biopsy technology since we introduced the first system more than 20 years ago."

The system is CE marked, and Hologic has begun installing Affirm prone systems at leading imaging sites in Europe. The Affirm prone biopsy system expands Hologic's breast biopsy portfolio, complementing the company's Genius 3D Mammography exam and Affirm upright biopsy system.