The American College of Radiology is urging the FDA to address ongoing shortages of stereotactic breast biopsy needles, warning that the supply constraints are disrupting patient access to diagnostic care nationwide.
The FDA added stereotactic breast biopsy needles to its medical device shortage list in mid-April and estimated shortages could continue through the rest of 2026, according to a May 15 ACR news release.
ACR leaders said the organization has received reports of “significant backorders from key manufacturers” that are creating “immediate and substantial challenges” for breast imaging practices. The group said the shortages began earlier this year after a “major manufacturer” halted shipments to address a product issue.
The ACR warned prolonged shortages could delay diagnoses of suspicious breast lesions, increase workflow inefficiencies and lead to more invasive and costly cancer cases. In a May 11 letter, the group asked the FDA to consider expedited review of alternative devices, temporary import pathways and additional coordination with manufacturers and federal agencies to stabilize supply.
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