#United States #Cincinnati #Mammotome #Breast Biopsy #Stereotactic Needle

Mammotome Enhances Manufacturing in Response to Breast Biopsy Needle Shortage

In a decisive move to combat the ongoing shortage of stereotactic breast biopsy needles, Mammotome, a prominent player in breast care innovation and a subsidiary of Danaher Corporation, has taken significant steps to increase its manufacturing capabilities. This initiative aims to address the critical needs of healthcare providers and ensure that patients maintain access to essential biopsy procedures, which play a crucial role in the diagnosis of breast cancer.

This shortage, recently acknowledged by the U.S. Food and Drug Administration (FDA), has been a pressing issue for many healthcare providers and institutions. The FDA added stereotactic breast biopsy needles to its Medical Device Shortages List, recognizing the operational hurdles it presents for many clinicians striving to provide timely diagnostic solutions for patients. The challenges associated with this shortage could extend well into the first quarter of 2027, raising concerns over prolonged delays in diagnosis and treatment for thousands of patients.

In response to these challenges, Mammotome has ramped up the production of its Mammotome Revolve™ Stereotactic Dual Vacuum-Assisted Breast Biopsy System and related consumables. The company is not only augmenting its production lines but also collaborating closely with suppliers to tackle supply chain constraints, ensuring that they can meet the rising demand from healthcare providers. Scott Treml, the Vice President and General Manager at Mammotome, emphasized that the urgency of responding to this shortage cannot be overstated. "Breast cancer diagnosis cannot wait, and neither can we," he stated, highlighting the company's commitment to providing reliable biopsy solutions quickly and efficiently.

To maintain a continuous flow of care, Mammotome is engaging with a broad range of stakeholders within the breast care community, from medical societies to health systems and supply chain partners. Their goal is to assess evolving needs and offer coordinated support throughout the duration of the shortage,
implementing a strategy that aligns with regulatory requirements and quality standards.

Mammotome's proactive measures demonstrate an understanding of the critical nature of timely breast cancer diagnosis. With over three decades of experience in the breast care sector, the company has built an extensive infrastructure comprising manufacturing capabilities, robust quality systems, and established clinical partnerships. This foundation allows them not only to respond to emergencies like this but also to maintain high standards of care for patients and providers alike.

As Mammotome accelerates its production and distribution efforts, clinicians are encouraged to reach out to their local representatives or visit Mammotome’s website for support. With prioritization given to maintaining access to biopsy tools, Mammotome is committed to ensuring that breast cancer patients do not face unnecessary delays in their diagnostic journey.

About Mammotome

Mammotome is recognized as an industry leader in breast care innovation, characterized by its commitment to enhancing patient outcomes through continual improvements in technology and quality of service. Headquartered in Cincinnati, Ohio, the company has been a part of Danaher Corporation since 2014 and supports healthcare providers in around 60 countries. Their extensive array of breast care products integrates precision, quality, and compassion, making them a trusted partner for clinicians and patients navigating the complexities of breast health.

About Danaher

Danaher Corporation is a global innovator in life sciences and diagnostics, dedicated to improving human health through scientific advancements and technology. With a robust framework that combines industry-leading businesses, Danaher works alongside its customers to tackle complex scientific challenges, thereby facilitating faster and more accurate diagnoses while driving down costs and risks associated with discovering and delivering vital therapies. Their commitment to operational excellence and continuous improvement empowers nearly 60,000 associates worldwide to impact quality of life significantly and build a healthier future.