Manufacturer ramps up production of breast biopsy needles amid shortage
A Cincinnati-based medical manufacturer is stepping up to assist with the ongoing breast biopsy needle shortage.
Mammotome announced that it was expanding its manufacturing capacity for stereotactic breast biopsy needles as a nationwide shortage continues to create challenges for breast imaging providers. In early 2026, Hologic issued an alert saying its Brevera Breast Biopsy System Disposable 9 Gauge Needles were being recalled due to the potential to leave behind metallic particles in tissue. This could cause several adverse effects, including foreign body reactions, hematoma/hemorrhage, infection and the risk of repeat biopsies.
By April, the needles made their way onto the U.S. Food and Drug Administration’s list of device shortages; not long after that, the FDA provided an update indicating that the shortage could persist through early 2027. Both the FDA and American College of Radiology have since encouraged users to find alternative devices to use during breast biopsy procedures so as to not delay care for those in need.
Hologic took steps to increase manufacturing of its the supply of Eviva biopsy needles to give it customers access to alternatives, and now Mammotome is doing the same. The company said it moved to increase production of its Revolve Stereotactic Dual Vacuum-Assisted Breast Biopsy System and associated consumables in response to the shortage. The company recently shared that it has added manufacturing capacity while working with suppliers to address supply chain challenges to meet the increased demand from providers who conduct breast biopsies.
"Breast cancer diagnosis cannot wait, and neither can we," Scott Treml, vice president and general manager at Mammotome, said in an announcement. "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."
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In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.