Mammotome, a Danaher company based in Cincinnati, has received FDA clearance for two products intended for MR-guided breast biopsy, including what the company describes as the first vacuum-assisted system designed for use inside the MR scanner room.

The Mammotome Prima MR dual vacuum-assisted breast biopsy system is designed to be positioned at the patient’s side within the MR suite, rather than outside the room. The company says this configuration is intended to support workflow by allowing clinicians to remain in closer proximity to the patient during procedures.

According to Mammotome, the system incorporates reduced tubing compared with conventional setups, which the company says enables stronger vacuum performance and supports the use of an 8-gauge needle for tissue sampling. The platform also includes a touchscreen interface that allows operators to adjust aperture size and vacuum settings during procedures.
The FDA also cleared the HydroMARK Plus breast biopsy site marker for MR, which is indicated for use with the Prima MR system’s targeting set. The marker uses a hydrogel and titanium design intended to maintain visibility under MR, including both T1 and T2 sequences. The company states that the marker is designed to remain in place after deployment and can be visualized with ultrasound for up to 12 months, including in patients undergoing neoadjuvant chemotherapy.

“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,” said Scott Treml, vice president and general manager of Mammotome.

The system previously launched in Europe and is expected to become available in the U.S. this summer. Mammotome said it plans to showcase both products at the 2026 Society of Breast Imaging symposium in April, with additional international rollout anticipated later this year.

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