Update on Biopsy Needle Availability
Hologic is committed to the highest quality and is working urgently to address market shortages following the field safety notice and removal of all Brevera® Breast Biopsy System 9 Gauge needles late last year. We are currently targeting Brevera’s return to market by the end of the calendar year 2026.
In the interim, we are committed to supporting customers’ operations through the following immediate actions:
- Enabling Standalone Imaging: U.S. customers can now operate the Brevera system as a standalone imaging unit to help maintain clinical workflows.
- Increasing Biopsy Needle Supply: We are significantly increasing the supply of Eviva® biopsy needles. This is backed by major investments in our internal manufacturing, including additional personnel resources and expanded manufacturing shifts.
- Expediting Product Delivery: We are expediting shipping on all orders to ensure customers receive essential supplies as quickly as possible.
- Stabilizing Inventory: Our teams are working closely with component suppliers to increase volumes and restore long-term inventory consistency.
Eviva needles continue to be allocated through a multi‑pronged approach that considers historical ordering patterns prior to the field action, procedure volume and inventory levels to support planning.
Throughout this process, we are working closely with the U.S. Food & Drug Administration and American College of Radiology, which has released new guidance to support the radiology community. We remain committed to providing regular updates here as they become available, and customers may contact their Hologic sales representative with any questions.
Overview
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Training
A proven and dependable solution for fast, compassionate, and easy breast biopsy.
At Hologic we are committed to minimizing the procedure’s impact on the patient and on the facility by designing clinically effective solutions that optimize facility workflows and create a better patient experience.
The Eviva Breast Biopsy system, designed for both prone and upright systems, offers multiple device options trusted Globally in nearly 3,000 facilities and in over 2.4 million biopsies.1
Fast
- Remove 6 consistent cores in under 30 seconds with 4.5 second biopsy cycle time.*
- Keep total control with manual needle rotation at your fingertips, no programming required.
- Manage patient bleeding without stopping the procedure with saline lavage and constant aspiration.
Compassionate
- Offer patients a positive cosmetic outcome with maximal core samples and minimal incision size.2
- Keep patients calm. Biopsy with a quiet remote pneumatic firing system that helps not startle the patient versus other adapter release systems.3
- Manage patient pain with local anesthetic directly to the biopsy site with every core.4
- Obscure blood from patient view with translucent color tubing.
Easy
- Optimize access to challenging lesions close to the chest wall using a low-profile needle.
- Manage a wide spectrum of patients with needle size, length, and aperture options.
- Manage thin breast compressions as small as 16mm.5
- Work seamlessly on Hologic’s market leading Affirm® prone and upright biopsy guidance systems with all needle parameters pre-programmed.4
- Easily mark the site with integrated site marking solutions.
Video Resources
Specifications
With multiple 9g and 12g needle options in standard and petite configurations; superficial, chest wall, and retroareolar lesions are easily handled by choosing the right needle for the task.
- Gauge: 9 or 12 gauge
- Length: 10 or 13 cm
- Aperture: 20 mm
- Throw/Stroke: 23 mm
- Gauge: 9 gauge
- Length: 10 or 13 cm
- Aperture: 12 mm
- Throw/Stroke: 15 mm
- Gauge: 9 gauge
- Length: 10 or 13 cm
- Aperture: 12 mm
Product Gallery
Total Solution
Faxitron® Core Specimen Radiography System.
Accelerate Your Procedure. Combine the Faxitron® Core Specimen Radiography System in your suite, to eliminate delays for core sample verifications with the core specimen radiography system designed to provide high-resolution imaging in the room, helping you accelerate procedures and get patients out of compression faster.
Breast Biopsy Markers
At Hologic, we have distinct shapes with options for great long-term ultrasound visibility. Designed so you can identify sites with confidence. Hologic provides an array of biopsy site marking options specific for the Eviva system, composed of bio-compatible permanent titanium, stainless steel, or nitinol.
