- Hologic Affirm Prone Biopsy System User's Manual Video
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- Affirm Prone Biopsy Table
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Sep 12, 2017 The Brevera system can be used with Hologic's Affirm prone biopsy system, Affirm breast biopsy guidance system and MultiCare Platinum system, and most upright and prone systems on the market. Is the first country to approve the sale of the solution. It is currently awaiting CE marking in Europe. Back to HCB News. Hologic won FDA clearance and is releasing its Affirm prone biopsy guidance system, a product already approved in Europe. The system provides both 2D and 3D image guidance for performing breast. Better Together: The Affirm ® prone and the Brevera ® Biopsy Systems When paired together, the Affirm ® prone system and the Brevera ® breast biopsy system with CorLumina ® imaging technology is designed to accelerate the speed and efficiency of prone biopsy procedures to minimize patient time under compression. 1999 Quality Control Manual Information By product of conducting Quality Control tests for Stereotactic Breast Biopsy units is greater familiarity with the operation and performance of your SBB system, particularly image quality and the accuracy of needle placement.
- Hologic, Inc. Modified Affirm Breast Biopsy Guidance Sy stem Special 510(k) Premarket Notification The Affirm Breast Biopsy Guidance System is an optional accessory for the Selenia Dimensions Mammography System.
- Affirm Prone Biopsy System. The Affirm prone biopsy system expands Hologic's breast biopsy portfolio to include a dedicated prone biopsy system, complementing Hologic’s 3D MAMMOGRAPHY™ technology and Affirm upright biopsy accessory for the Selenia® Dimensions® mammography system. This portfolio equips hospitals and imaging centers with.
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DESCRIPTION
Breast biopsy system for stereotacticThe ATEC breast biopsy system is a proven solution with fast tissue acquisition that minimizes patient pain, providing physicians a platform to deliver compassionate care in a safe, accurate and efficient way.
FORUMSView All (1)
Ask a New Question2Replies2 years ago | 2 years agoPreventive Maintenance Does anyone have a Preventive Maintenance form for the ATEC Pearl?Reply |
DOCUMENTS / MANUALSView All
FEATURES
Fast
- Tissue acquisition occurs every 4.5 seconds, typically lasts less than 30 seconds total.
- Easily delivers local anesthetic without interruption. Saline lavage and constant aspiration assists in consistent core retrievalSafe
- Closed system reduces contamination risk.
- Fully disposable device and tubing minimizes staff and patient exposure to biohazardSimple
- Simple one minute set-up and clean-up.
- No software required for user to program or operate the console.
SERIES MODELS
Height | 37 in |
Length | 21 in |
Weight | 100 lbs |
Width | 25 in |
Additional Specifications |
Height | 37 in |
Length | 21 in |
Weight | 100 lbs |
Width | 25 in |
Additional Specifications |
Height | 37 in |
Length | 21 in |
Weight | 100 lbs |
Width | 25 in |
Additional Specifications |
MARLBOROUGH, Mass., April 21, 2016 /PRNewswire/ -- Hologic, Inc. (Nasdaq: HOLX) today announced the U.S. Food and Drug Administration (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.
'At Hologic, we challenge ourselves to advance medical technology so that healthcare professionals and patients can benefit from innovative solutions that significantly improve outcomes and patient experience, while also creating a powerful economic model for our customers,' said Pete Valenti, Hologic's Division President, Breast and Skeletal Health Solutions. '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. We identified a need for a minimally invasive, stereotactic breast biopsy technology that marries the advances in 3D MAMMOGRAPHY exams with the prone positioning many doctors prefer, and are excited to bring this new generation prone biopsy system to market.'
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. Approach angles can be varied with minimal movement on the patient's part, as the patient is supported stably throughout the procedure. In addition to these important benefits for clinicians, the system's design aims to increase patient satisfaction through faster procedure times than Hologic's market leading 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 3D MAMMOGRAPHY exams,' said Dr. Alejandro Tejerina 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.
The Affirm prone biopsy system expands Hologic's breast biopsy portfolio, complementing the Company's Genius 3D MAMMOGRAPHY exam and Affirm upright biopsy system. This portfolio equips hospitals and imaging centers with the options necessary to provide minimally invasive breast biopsies for their patients.
The system is now available for order in the U.S. For additional information on the Affirm prone biopsy system, please visit www.affirmpronebiopsy.com.
Hologic Affirm Prone Biopsy System User's Manual Video
About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Company's core business units focus on diagnostics, breast health, GYN surgical and skeletal health. With a unified suite of technologies and a robust research and development program, Hologic is dedicated to The Science of Sure. For more information on Hologic, visit www.hologic.com.
Hologic, 3D, 3D Mammography, Affirm, Genius, MultiCare and the Science of Sure are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.
Hologic Affirm Prone Biopsy System User's Manual Youtube
Forward-Looking Statements
Affirm Prone Biopsy Table
This news release may contain forward-looking information that involves risks and uncertainties, including statements about the use of Hologic mammography and breast biopsy systems. There can be no assurance the systems will achieve the benefits described here, or that such benefits will be replicated in any particular manner with respect to an individual patient. The actual effect of the use of the systems can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. In addition, there can be no assurance that the systems will achieve any expected level of sales or market share. Hologic expressly disclaims any obligation to release publicly any updates to the data or statements presented here to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.
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To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/hologic-announces-fda-clearance-and-commercial-availability-of-the-affirm-prone-biopsy-system-the-first-2d3d-imaging-guided-dedicated-prone-biopsy-system-300255079.html
SOURCE Hologic, Inc.