FDA clears 2 new MR-guided breast biopsy tools
The U.S. Food and Drug Administration this week cleared two new breast biopsy tools designed to improve the procedure process for both patients and providers.
Mammatome, a company that specializes in diagnostic breast care, announced the clearance of two products used during MR-guided breast biopsies—the Mammotome Prima MR Dual Vacuum-Assisted Breast Biopsy System, and the HydroMARK Plus Breast Biopsy Site Marker for MR.
The company maintains that its vacuum-assisted breast biopsy is the industry's first such tool designed to be positioned in the MRI scanner room at the patient's side. This capability helps to streamline the entire procedure, and the system’s intuitive in-room design simplifies both the set up and clean up. The system requires 75% less tubing and uses an eight-gauge needle, which allows providers to acquire bigger tissue samples (78% larger on average when compared to similar products).
The HydroMARK Plus Breast Biopsy Site Marker was developed to be used exclusively alongside the Mammotome Prima MR universal targeting set. It utilizes hydrogel technology and titanium shapes that provide visibility under both T1 and T2 MRI sequences without excessive bloom. When it attaches to tissue, it deploys “wings” to prevent displacement during excision and can remain in place for up to 12 months.
"The Mammotome Prima MR system paired with the new HydroMARK Plus marker for MR offers clinicians in the United States a first‑of‑its‑kind MR solution designed for efficiency, precision, and ultimately, an improved patient experience,” Scott Treml, vice president and general manager of Mammotome, said in a statement on the clearances.
Mammotome expects the system to be available for commercial use in the U.S. later this summer. It will be featured in April at the 2026 Society of Breast Imaging Symposium.
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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.