Mammotome Secures FDA Clearance for Industry-First, In‑Room MR Vacuum‑Assisted Breast Biopsy System and New HydroMARK™ Plus MR Biopsy Site Markers

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Mar 18, 2026, 08:00 ET

CINCINNATI, March 18, 2026 /PRNewswire/ -- Mammotome, a Danaher company, announces FDA Clearance of two innovations for MR-guided breast biopsy: the Mammotome Prima™ MR Dual Vacuum-Assisted Breast Biopsy System – the industry's first solution designed to be positioned in the MRI scanner room at the patient's side – and the HydroMARK™ Plus Breast Biopsy Site Marker for MR, engineered for exclusive use with the Mammotome Prima™ system universal targeting set. Following a successful debut of the Mammotome Prima™ MR system in Europe, both products will be introduced to U.S. clinicians at the 2026 Society of Breast Imaging (SBI) Symposium. By bringing the device directly into the scanner room, the Mammotome Prima™ MR system enhances clinician coordination, streamlines communication, and helps maintain consistent focus on the patient throughout the procedure.

The Mammotome Prima™ MR system and the HydroMARK™ Plus marker for MR.

The Mammotome Prima™ MR system features an intuitive in-room design¹that simplifies setup and operation. Clinicians benefit from larger tissue samples² enabled by stronger vacuum³ and an 8-gauge needle, made possible by 75% less tubing compared to other systems⁴. The reduced tubing also supports faster setup and cleanup. A touchscreen interface allows convenient adjustments to aperture size and vacuum strength.

FDA clearance of the HydroMARK™ Plus Breast Biopsy Site Marker for exclusive use with the Mammotome™ Prima MR universal targeting set delivers added confidence for MR-guided breast biopsy procedures. Its intuitive integration with the targeting sleeve⁵ allows consistent and accurate deployment into the biopsy cavity⁶. The HydroMARK™ Plus marker incorporates the exclusive hydrogel technology and titanium shapes that provide visibility under both T1 and T2 MRI sequences without excessive bloom⁵. In addition, the marker is designed to attach to tissue upon deployment and features "wings" designed to mitigate displacement during surgical excision⁷. Its long-term ultrasound visibility – lasting up to 12 months, even after neoadjuvant chemotherapy – supports reliable pre-surgical localization and continuity from biopsy through surgery^8,9.

"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.

With the FDA clearance of the Mammotome Prima™ MR system and the HydroMARK™ Plus marker for MR, Mammotome expands its portfolio with an integrated solution designed to support precision, efficiency and confidence in the MR suite. The system will be available to U.S. clinicians this summer and will be featured at the 2026 Society of Breast Imaging (SBI) Symposium in April. Rollout to additional countries around the world is also planned for later this year. To learn more, visit mammotome.com.

	1.	Compared to the Hologic ATEC® system based on a survey of 16/16 (100%) MRI technologists currently using the Hologic ATEC® system, after using the Mammotome Prima™ system.
	2.	Mammotome Prima™ MR 8G probe compared to the Hologic ATEC® 9G yielded 78.6% higher average sample weight based on porcine lab data from 120 tissue samples for each group of devices.
	3.	Measured at the aperture, compared to the Hologic ATEC® breast biopsy system based on benchtop testing.
	4.	Compared to the Hologic ATEC® standard MR probe tubing and the BD Encor Enspire™ MR probe with tubing extension.
	5.	HydroMARK™ Plus Device Test - PCR-000979 Summative, ES-002827 Claims Assessment
	6.	HydroMARK™ Plus Device Test - PCR-000747 Verification, SDR0124 Applicator Installation Testing. PCR-000743 Animal Testing, SDR0110 Animal Testing
	7.	HydroMARK™ Device Test - PCR-000299, SDR0098 Vacuum Suction Testing
	8.	Sakamoto, N., Fukuma, E., Tsunoda, Y. et al. Evaluation of the dislocation and long-term sonographic detectability of a hydrogel based breast biopsy site marker. Breast Cancer 25, 575–582 (2018). https://doi.org/10.1007/s12282-018-0854-8
	9.	Gentile, Ann Surg Oncol. 2016 Oct;23(10):3284-9. doi: 10.1245/s10434-016-5325-x. Epub 2016 Jun 23.

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 over 45 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. Our businesses partner closely with customers to solve many of the most important health challenges impacting patients around the world. Danaher's advanced science and technology - and proven ability to innovate - help enable faster, more accurate diagnoses and help reduce the time and cost needed to sustainably discover, develop and deliver life-changing therapies. Focused on scientific excellence, innovation and continuous improvement, our approximately 63,000 associates worldwide help ensure that Danaher is improving quality of life for billions of people today, while setting the foundation for a healthier, more sustainable tomorrow. Explore more at www.danaher.com.

SOURCE MAMMOTOME