Towards Healthcare Research & Consulting

U.S. Breast Biopsy Devices Top Companies and Strategic Involvements

Date : 07 April 2026

Top Companies in the U.S. Breast Biopsy Devices Market & Their Offerings

U.S. Breast Biopsy Devices Market Companies are Hologic, Inc., Mammotome (Danaher), BD (Becton Dickinson), Argon Medical Devices, Merit Medical Systems, GE HealthCare

  • All your U.S. Breast Biopsy Devices Market insights, streamlined and simplified - Access the dashboard.
Companies Headquarters Offerings
Hologic, Inc. Massachusetts, USA provides minimally invasive and image-guided breast biopsy systems, specimen imaging tools, and integrated breast health solutions
Mammotome (Danaher) Ohio, USA specializes in vacuum-assisted biopsy devices and lesion localization solutions for hospitals and imaging centers.
BD (Becton Dickinson) New Jersey, USA offers vacuum-assisted and multi-modality biopsy systems, consumables, and precision interventional tools.
Argon Medical Devices Texas, USA delivers core needle and semi-automatic biopsy instruments along with localization products for breast procedures.
Merit Medical Systems Utah, USA provides core needle and automated biopsy devices designed for accurate image-guided sampling.
GE HealthCare Illinois, USA offers advanced imaging systems like mammography, MRI, and ultrasound that support breast biopsy procedures and diagnostics. 

What are the Recent Developments in the U.S. Breast Biopsy Devices Market?

  • In February 2026, Mammotome introduced a new MRI-room compatible vacuum-assisted breast biopsy system that can be placed beside the patient during the procedure. This advancement helps improve workflow, supports smoother clinician coordination, and enhances patient-focused care during MRI-guided biopsies.
  • In January 2026, BD received FDA 510(k) clearance for its EnCor EnCompass Breast Biopsy and Tissue Removal System. The newly approved system supports multiple imaging techniques, giving clinicians greater flexibility and improving minimally invasive breast disease diagnosis, while further strengthening BD’s breast biopsy product portfolio.

Supply Chain Analysis

R&D

  • R&D in the U.S. breast biopsy devices market is focused on improving minimally invasive techniques, vacuum-assisted systems, and AI-powered guidance to boost accuracy, speed up procedures, and enhance patient comfort.
  • Key players: Hologic, Devicor Medical, Becton Dickinson, Medtronic, and Siemens Healthineers.

Clinical Trials

  • Clinical trials in the U.S. breast biopsy devices market aim to enhance precision, minimize invasiveness, and incorporate real-time imaging. Recent innovations include AI-assisted guidance, compact handheld devices, and advanced vacuum-assisted systems.
  • Key players: Devicor Medical, Hologic, Becton Dickinson, Merit Medical, and Cook Medical.

Packaging and Serialization

  • Packaging and serialization of U.S. breast biopsy devices follow FDA requirements for safety and traceability, including UDI and, for combination products, DSCSA standards. Sterile-barrier solutions like pouches and trays maintain sterility, while 2D DataMatrix codes allow full supply chain tracking.
  • Key players: BD, Medtronic, Cardinal Health, Hologic, and Siemens Healthineers