Hologic receives FDA approval of prone biopsy system

Hologic 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.

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.

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.

For additional information on the Affirm prone biopsy system, please visit www.affirmpronebiopsy.com.
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