Mammotome Secures FDA Clearance for Industry-First, In‑Room MR Vacuum‑Assisted Breast Biopsy System and New HydroMARK™ Plus MR Biopsy Site Markers
Published: 08 Apr 2026
Author: Towards Healthcare
Mammotome, a Danaher company, announces FDA Clearance of two innovations 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.
MR system in Europe, both products will be introduced to U.S. clinicians at the 2026 Society of Breast Imaging (SBI) Symposium. By directly introducing this device into the scanner room, the Mammotome Prim MR system enhances clinician coordination, streamlines communication, and helps maintain a consistent focus on the patient throughout the procedure.
The Market is Driven by Awareness of Rising Breast Cancer
According to Towards Healthcare, the U.S. breast biopsy devices market is projected to experience significant growth, with estimates suggesting the market size will increase from USD 2.1 billion in 2026 to approximately USD 4.13 billion by 2035, representing a compound annual growth rate (CAGR) of 7.8% from 2026 to 2035. Growth is driven by increasing breast cancer prevalence, with independent diagnostic centres and ambulatory care facilities increasingly adopting advanced biopsy systems. The AI enhancement workflow and 3D imaging-guided platform have improved procedural efficiency and opening new revenue stream.
Breast Biopsy
In the U.S., breast cancer is the most commonly diagnosed cancer among women, with hundreds of thousands of new invasive and non-invasive cases reported annually, prompting more routine screening and follow-up biopsies when abnormalities are detected on imaging.
As incidence rates climb and screening programs expand, healthcare providers provide more biopsies to confirm diagnoses, guide treatment decisions, and rule out malignancy by boosting the utilisation of core-needle, vacuum-assisted, and image-guided breast biopsy devices.
About Mammotome
Headquartered in Cincinnati, OH, Mammotome has been part of the Danaher Corporation since 2014. At Mammotome, our expertise for breast care make the indispensable partner with physicians, clinicians, and patients, serving people with the clinicians and surgeons who demand consistently precise solutions, to the patients and families seeking peace of mind.
A recent report by Towards Packaging highlights that the U.S. breast biopsy devices market is witnessing MR-guided breast biopsy, which combines precision, efficiency, and patient-centred design to improve outcomes and procedural confidence for clinicians. System reduce procedural complexity and increases confidence in MR-guided biopsies.