Hologic’s Affirm prone biopsy system secures FDA clearance

24 April 2016 (Last Updated April 24th, 2016 18:30)

Hologic has secured US Food and Drug Administration (FDA) clearance and has commercially launched the Affirm prone biopsy system.

Affirm

Hologic has secured US Food and Drug Administration (FDA) clearance and has commercially launched the Affirm prone biopsy system.

The company is a developer, manufacturer and supplier of diagnostic and medical imaging systems related to women's health.

It is claimed to be the first dedicated prone biopsy system to generate both 2D and 3D imaging-guided breast biopsies.

The new technology gives radiologists the ability to better target lesions detected during 3D Mammography exams, as well as other screening modalities.

The Affirm prone biopsy system features a streamlined workflow with an enhanced automation, designed to make the process fast and easy.

The biopsy system offers a 360° access to lesions using a fully integrated C-Arm. Approach angles can be adjusted with minimal movement on the patient's part, as the patient is supported stably throughout the procedure.

Additionally, the system's design is aimed at improving patient satisfaction through faster procedure and comfortable prone positioning that negates a direct view of the biopsy needle.

Centro Patologia de la Mama, Fundación Tejerina Dr Alejandro Tejerina said: "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.

"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 visualise more tissue and have access to challenging lesion locations, and the procedures are very fast."

"We are able to visualise more tissue and have access to challenging lesion locations, and the procedures are very fast."

After securing a CE mark, Affirm prone systems have been installed by Hologic across the imaging sites in Europe.

The system adds to Hologic's breast biopsy portfolio, complementing its Genius 3D Mammography exam and Affirm upright biopsy system.

Hologic's current portfolio of technology caters to the hospitals and imaging centre's requirement for minimally invasive breast biopsies for their patients.


Image: Hologic's Affirm prone biopsy system. Photo: courtesy of Hologic, Inc.