Hologic Affirm Breast Biopsy Guidance System: Precision Targeting for Minimally Invasive Breast Biopsies

When a screening or diagnostic mammogram reveals a suspicious finding, the next step is often a tissue biopsy to determine whether the abnormality is benign or malignant. The Hologic Affirm Breast Biopsy Guidance System is purpose-built for this critical clinical moment, providing interventional radiologists and breast surgeons with real-time stereotactic and tomosynthesis-guided targeting to localize and sample suspicious lesions with exceptional accuracy.

For breast imaging facilities looking to offer comprehensive in-house biopsy services, the Affirm system integrates directly with Hologic's Selenia Dimensions and 3Dimensions mammography platforms, transforming a screening unit into a complete diagnostic and interventional breast imaging solution. ARRAD provides both new and refurbished Hologic Affirm systems with full installation, training, and 24/7 technical support.

What Is Stereotactic Breast Biopsy?

Stereotactic breast biopsy is a minimally invasive procedure that uses X-ray imaging from multiple angles to calculate the precise three-dimensional location of a suspicious area within the breast. Once the target is localized, the radiologist advances a biopsy needle to the exact coordinates, retrieves tissue samples, and sends them for pathology analysis.

Compared to open surgical biopsy, stereotactic breast biopsy offers several important advantages for both patients and facilities:

• Minimally Invasive: Performed through a small skin incision (typically 3-4 mm) rather than a surgical excision, resulting in less scarring, faster recovery, and reduced patient discomfort.
• Outpatient Procedure: Most stereotactic biopsies are completed in 30 to 60 minutes and require only local anesthesia, allowing patients to return to normal activities within 24 hours.
• High Diagnostic Accuracy: When performed with proper image guidance, stereotactic biopsy achieves diagnostic concordance rates exceeding 95%, providing reliable pathology results without the cost and recovery time of surgical excision.
• Cost Effective: Stereotactic biopsy costs significantly less than surgical biopsy, reducing financial burden for patients and payers while delivering equivalent diagnostic value.

How the Hologic Affirm System Works

The Hologic Affirm attaches directly to a compatible Hologic mammography gantry, converting the system from a standard screening/diagnostic unit into a precision-guided biopsy platform. This integrated design eliminates the need for a separate dedicated biopsy system in many facilities, reducing capital equipment costs and simplifying room scheduling.

During a biopsy procedure, the workflow follows these steps:

• Target Acquisition: The radiologist uses stereo pair images (two angled exposures) or tomosynthesis-guided imaging to identify and target the suspicious lesion. The system calculates the exact X, Y, and Z coordinates of the target within the compressed breast.
• Needle Positioning: Using the computed coordinates, the biopsy needle guide positions the needle at the precise target location. The Affirm system supports both lateral and vertical needle approaches, accommodating a wide range of lesion locations within the breast.
• Tissue Sampling: The radiologist advances the biopsy device (vacuum-assisted or spring-loaded core needle) to the target and retrieves tissue samples. Confirmation images verify that the needle traversed the target area.
• Marker Placement: After sampling, a tissue marker clip is typically placed at the biopsy site to mark the location for future reference or surgical planning if needed.

Tomosynthesis-Guided Biopsy Capability

One of the most significant advantages of the Hologic Affirm system is its ability to perform tomosynthesis-guided biopsies. While traditional stereotactic biopsy relies on two-dimensional stereo pair images for targeting, tomosynthesis guidance uses the same 3D imaging technology available on the Selenia Dimensions platform to visualize the target in thin slices.

This capability is particularly valuable for lesions that are visible only on 3D tomosynthesis images and cannot be adequately localized using conventional 2D stereotactic techniques. As more facilities adopt 3D mammography for screening, the number of findings detected exclusively on tomosynthesis has increased, making tomosynthesis-guided biopsy capability an essential service for comprehensive breast imaging programs.

Clinical benefits of tomosynthesis-guided biopsy include:

• Ability to target lesions visible only on 3D tomosynthesis
• Improved targeting accuracy for subtle architectural distortions and small calcification clusters
• Reduced procedure time compared to some stereotactic approaches
• Enhanced confidence in needle placement verification

Integration with Hologic Mammography Platforms

The Affirm system is designed to integrate seamlessly with Hologic's mammography platforms, including the Selenia Dimensions and 3Dimensions (Genius) systems. This integration provides several practical advantages for breast imaging facilities:

Shared Platform: The Affirm attachment converts your existing mammography unit into a biopsy system, eliminating the need to purchase and maintain a separate dedicated biopsy platform. This approach reduces capital costs and maximizes the utilization of your mammography investment.

Workflow Continuity: Because the Affirm uses the same gantry, detector, and workstation as your screening mammography system, your staff works within a familiar interface. This reduces learning curves and supports efficient procedure scheduling.

Room Flexibility: When the Affirm attachment is not in use, the mammography system remains available for routine screening and diagnostic imaging. Switching between screening mode and biopsy mode typically takes only a few minutes.

Clinical Applications

The Hologic Affirm supports a range of interventional breast procedures beyond standard core needle biopsy:

Vacuum-Assisted Biopsy: Compatible with standard vacuum-assisted biopsy devices (including Hologic's ATEC and Eviva systems), allowing retrieval of larger tissue volumes for improved diagnostic accuracy, especially for calcification clusters and small masses.

Preoperative Needle Localization: For lesions requiring surgical excision, the Affirm system can guide placement of localization wires or radiofrequency markers to assist the surgeon in identifying the target during surgery.

Upright and Lateral Approaches: The system supports both upright (standard) and lateral (side-approach) biopsy techniques, enabling access to lesions in virtually any location within the breast, including those close to the chest wall or in the axillary tail.

Building a Comprehensive Breast Imaging Program

Adding the Hologic Affirm to your mammography suite creates a complete breast imaging workflow within a single room. Facilities that offer in-house biopsy services benefit from:

Reduced Patient Referrals: Instead of referring patients to external facilities for biopsy, your team can perform the procedure on-site. This improves patient convenience, reduces time to diagnosis, and keeps the clinical relationship within your facility.

Increased Revenue: Breast biopsy is a well-reimbursed procedure that adds a meaningful revenue stream to your breast imaging program. The incremental investment in the Affirm attachment is typically recovered through biopsy volume within the first year of operation.

Improved Patient Experience: Patients benefit from having their screening, diagnostic workup, and biopsy performed in a single location by a familiar care team. This continuity reduces anxiety and improves satisfaction scores.

Competitive Differentiation: Facilities offering comprehensive breast imaging services, including 3D mammography and in-house biopsy, attract referring physicians and patients who value convenience and clinical excellence.

New and Refurbished Options from ARRAD

ARRAD offers the Hologic Affirm Breast Biopsy Guidance System in both new and professionally refurbished configurations. New systems include the latest hardware and software with full manufacturer support. Refurbished systems provide an excellent value for facilities adding biopsy capability at a lower capital investment.

Every Affirm system from ARRAD includes:

• Complete system installation and integration with your Hologic mammography platform
• Hands-on training for interventional radiologists, technologists, and support staff
• Warranty coverage with flexible terms
• 24/7 technical support with remote diagnostics capability
• Access to OEM replacement parts through radmedparts.com

Installation and Training

Installing the Affirm system on a compatible Hologic mammography unit is a straightforward process that typically requires 1 to 2 days. Because the Affirm is an attachment rather than a standalone system, site preparation requirements are minimal; your existing mammography room, electrical infrastructure, and radiation shielding are already in place.

Training is a critical component of a successful biopsy program. ARRAD provides comprehensive training that covers:

• System setup and attachment procedures
• Target acquisition using stereo pair and tomosynthesis guidance
• Needle positioning and tissue sampling techniques
• Post-biopsy verification and marker placement
• Quality assurance and maintenance protocols
• Patient positioning and comfort optimization

For facilities new to breast biopsy, we also coordinate with clinical educators who can provide mentored case support during your initial procedures to build confidence and proficiency.

Service and Support

ARRAD stands behind every Affirm system with comprehensive technical support designed to maximize your system's uptime and your team's confidence in the equipment.

24/7 Technical Support: Our nationwide service network operates around the clock. When issues arise, our team responds through remote diagnostics or dispatches field service technicians as needed.

Preventive Maintenance: Scheduled maintenance programs address routine servicing, performance verification, and early identification of potential issues before they impact clinical operations.

Parts Availability: Through radmedparts.com, ARRAD maintains inventory of OEM replacement parts for the Affirm platform, ensuring fast availability when components need replacement.

Get a Quote for the Hologic Affirm System

Whether you are building a new breast imaging program, expanding an existing mammography suite to include biopsy services, or replacing an aging biopsy platform, the Hologic Affirm Breast Biopsy Guidance System is a proven solution that delivers precision, reliability, and clinical value.

Contact ARRAD today at 877.299.8303 or request a quote online to discuss your facility's needs. Our team will help you evaluate compatibility with your current Hologic mammography system, configure the right setup, and plan installation and training. You can also reach us at info@arrad.net. Our office is located at 25652 Commercentre Dr, Lake Forest, CA 92630.