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

Related Content

Densitas Enters Partnership Agreement With TeleMammography Specialists
News | Breast Density | February 14, 2019
Breast imaging analytics company Densitas Inc. announced a new collaboration partnership with TeleMammography...
Hologic Launches Unifi Analytics Business Intelligence Tool
Technology | Analytics Software | February 12, 2019
Hologic Inc. announced the U.S. launch of Unifi Analytics, a business intelligence tool that allows healthcare...
Mount Sinai's Digital 3-D Mammography Van Rolls Into New York City
News | Mammography | February 11, 2019
Mount Sinai Hospital recently launched the Mount Sinai Mobile Mammography Program (MMP), bringing essential breast...
breast density cancer awareness
News | Breast Density | February 08, 2019
Governor Michelle Lujan Grisham has signed breast density inform bill, ...
Fujifilm Launches Latest Synapse 3D Version at HIMSS 2019

The new Intravoxel Incoherent Motion (IVIM) MR application in Synapse 3D

Technology | Advanced Visualization | February 08, 2019
Fujifilm Medical Systems U.S.A. will debut the latest version of its Synapse 3D solution at the Healthcare Information...
Siemens Healthineers Syngo.Breast Care Adding AI-Based Decision Support
News | Clinical Decision Support | February 05, 2019
Siemens Healthineers showcased the new planned artificial intelligence (AI)-based features with its mammography reading...
 Volpara Solutions Launches Next-Generation VolparaDensity Software to Support SmartCurve Paddles
Technology | Breast Density | January 31, 2019
Volpara Solutions Inc. received U.S. Food and Drug Administration (FDA) 510(k) clearance for new technologies used in...
QTbreasthealth Opens New Breast Ultrasound Imaging Center in Grand Rapids
News | Ultrasound Women's Health | January 30, 2019
January 30, 2019 — QTbreasthealth launched a center in Grand Rapids, Mich., featuring its quantitative transmission
Traditional mammography continues to be the gold standard for breast cancer screening technologies. However, use of 3-D breast tomosynthesis is growing rapidly.

Traditional mammography continues to be the gold standard for breast cancer screening technologies. However, use of 3-D breast tomosynthesis is growing rapidly.

Feature | Breast Imaging | January 30, 2019 | By Jeff Zagoudis
The importance of early detection of...
Wefight Unveils Vik Breast Chatbot at CES 2019
News | Artificial Intelligence | January 25, 2019
French startup company Wefight unveiled the English version of its Vik Breast chatbot for breast cancer patients at the...