Technology | Breast Biopsy Systems | April 21, 2016

Hologic Announces FDA Clearance, Launch of Affirm Prone Biopsy System

New system pairs 360-degree breast access with 2-D/3-D image guidance

Hologic, FDA approval, launch, Affirm prone biopsy system, breast cancer, women's health

April 21, 2016 — Hologic Inc. announced the U.S. Food and Drug Administration (FDA) clearance and commercial launch of the Affirm prone biopsy system. The company calls Affirm the first dedicated prone biopsy system to offer both 2-D and 3-D imaging-guided breast biopsies.

With a larger field of view than existing dedicated prone biopsy systems, the Affirm prone biopsy system allows radiologists to better target lesions found during 3-D 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. Approach angles can be varied with minimal movement on the patient's part, as the patient is supported stably throughout the procedure. In addition, the system's design aims to increase patient satisfaction through faster procedure times than Hologic's MultiCare Platinum system and comfortable prone positioning that eliminates a direct view of the biopsy needle.

"Until now, we've been struggling to handle complex biopsies for subtle lesions or faint calcifications that we are only able to identify using 3-D mammography exams," said Alejandro Tejerina, M.D., of the Centro Patologia de la Mama, Fundación Tejerina in Madrid, Spain. "As an early testing site for the Affirm prone biopsy system, we've had the opportunity to perform many biopsies using this technology, and are pleased to report that this new biopsy table has helped to solve our challenges. We are able to visualize more tissue and have access to challenging lesion locations, and the procedures are very fast."

The system is CE marked, and Hologic has begun installing Affirm prone systems at leading imaging sites in Europe.

For more information: www.hologic.com

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