Mammotome Expands Production to Address Breast Biopsy Needle Shortage

Cincinnati-based Mammotome, a Danaher Company, has expanded its production capacity and increased support for healthcare providers in response to a nationwide shortage of stereotactic breast biopsy needles. The shortage, first notified by the U.S. Food and Drug Administration (FDA) earlier this year, has posed significant operational challenges for clinicians and health systems striving to maintain timely diagnostic pathways for patients.

The shortage is expected to continue through the end of the first quarter of 2027, raising concerns about potential delays in breast cancer diagnosis. Mammotome, a global leader in breast care innovation, responded swiftly by scaling the production of its Mammotome Revolve™ Stereotactic Dual Vacuum-Assisted Breast Biopsy System and related consumables. The company worked closely with suppliers to address these challenges and meet the heightened needs of healthcare providers.

"Breast cancer diagnosis cannot wait, and neither can we," stated Scott Treml, Vice President and General Manager at Mammotome. "Our teams acted quickly and responsibly to scale production, applying the operational discipline and quality focus that guide our work every day. This is about speed with certainty: getting reliable biopsy solutions into the hands of clinicians and ensuring patients can access the care they need, when they need it."

To further support the broader public health response, Mammotome is collaborating with the broader breast care community, including medical societies, provider networks, health systems, and supply chain partners. The company is accelerating the production and deployment of available biopsy solutions, ensuring they align with applicable regulatory requirements, quality standards, and the needs of healthcare providers.

"During supply disruptions, continuity of access to biopsy tools is essential to keeping breast care pathways moving," added Treml. "We've spent more than three decades building the manufacturing depth, quality systems, and clinical partnerships that allow us to respond with urgency, confidence, and care. By working side-by-side with providers and applying disciplined execution, we're helping sustain timely access to the breast care solutions patients depend on."