Mammotome Accelerates Production as Public Health Response to Nationwide Breast Biopsy Needle Shortage

Cincinnati-based breast care company expands capacity and provider support to help minimize diagnostic delays and restore patient access to critical procedures

CINCINNATI, Sept. 3, 2026 /PRNewswire/ -- Mammotome, a Danaher Company and global leader in breast care innovation, has expanded manufacturing capacity and accelerated support for healthcare providers to help maintain patient access to breast biopsy procedures during the ongoing national shortage of stereotactic breast biopsy needles. Breast biopsy is a critical step in moving from discovery of suspicious imaging findings to diagnostic insight, and delays can create added uncertainty and slow the path to treatment.

Earlier this year, the U.S. Food and Drug Administration (FDA) notified providers of interruptions in the supply of stereotactic breast biopsy needles and added them to its Medical Device Shortages List. The shortage has created operational challenges for clinicians and health systems working to maintain timely diagnostic pathways for patients and is expected to extend through the end of the first quarter of 2027.

Recognizing the potential impact on timely breast cancer diagnosis, Mammotome moved early to scale production of the Mammotome Revolve™ Stereotactic Dual Vacuum-Assisted Breast Biopsy System and related consumables, adding capacity while working closely with suppliers to solve these challenges and respond to increased provider needs. These efforts are intended to help support the broader public health response by enabling more care sites to maintain access to the biopsy tools needed to keep diagnostic pathways moving and provide answers to patients and their families.

"Breast cancer diagnosis cannot wait, and neither can we," said Scott Treml, Vice President and General Manager at Mammotome. "When the shortage emerged, 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 making sure patients can get the care they need, when they need it."

Mammotome is also collaborating with the broader breast care community, including medical societies, provider networks, health systems and supply chain partners, to understand evolving needs, coordinate support and help maintain continuity of care throughout the shortage. The company is accelerating production and deployment of available biopsy solutions as quickly as possible, in alignment with applicable regulatory requirements, quality standards and healthcare provider needs.

"During supply disruptions, continuity of access to biopsy tools is essential to keeping breast care pathways moving," Treml added. "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."

Clinicians working to maintain access to breast biopsy solutions are encouraged to contact their local Mammotome representative or visit Mammotome.com.

About Mammotome:

At Mammotome, our expertise and compassion for breast care makes us the indispensable partner to physicians, clinicians and patients. Our drive for innovation is rivaled only by our compassion for the people we serve, from the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind. We boast a comprehensive range of products that create better outcomes in breast care and provide physicians and patients with educational resources that guide their journey. Headquartered in Cincinnati, OH, Mammotome has been part of the Danaher Corporation since 2014. The Mammotome brand of products is sold in about 60 different countries throughout the world.

About Danaher:

Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

FDA Medical Device Shortages List (As of June 2026): https://www.fda.gov/medical-devices/medical-device-supply-chain-and-shortages/medical-device-shortages-list#shortage 

FDA Disruptions in Availability of Breast Biopsy Needles – Letter to Health Care Providers (As of June 2026) https://www.fda.gov/medical-devices/letters-health-care-providers/disruptions-availability-breast-biopsy-needles-letter-health-care-providers

SOURCE Mammotome