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Science| 6/4/2026, 8:06:00 AM

Mammotome Expands Innovative Breast Biopsy Site Marker Access Across Europe

Mammotome Expands Innovative Breast Biopsy Site Marker Access Across Europe

Mammotome, a global leader in breast care innovation and part of the Danaher Corporation, has secured a CE mark for the HydroMARK Plus Breast Biopsy Site Marker. This significant development expands access to the cutting-edge marker technology across Europe, aiming to enhance the diagnosis and treatment of breast cancer for thousands of patients.

The HydroMARK Plus markers are designed to provide improved tissue adherence and mitigate marker displacement during surgical excision. By combining proprietary hydrogel technology with innovative features known as Wings that Cling, these markers offer enhanced stability and visibility in breast care. The hydrogel carrier is designed to hydrate within 24 hours and maintain ultrasound visibility for up to 12 months, including in patients undergoing neoadjuvant chemotherapy.

The importance of accurate lesion localization cannot be overstated in breast cancer diagnosis and treatment. The HydroMARK Plus markers address this need by being visible under ultrasound, mammography, and MRI, and are indicated for placement in both breast tissue and lymph nodes. This multifaceted approach ensures that clinicians have the tools they need to guide patients through their treatment with confidence.

According to Olaf Andrich, General Manager of EMEA at Mammotome, the HydroMARK Plus markers were designed with a focus on marker stability and visibility. This focus is in direct response to the priority of mitigating the risk of surgical displacement, a critical concern for breast care teams. By securing the CE mark, Mammotome has taken a significant step towards making this technology available across Europe, reflecting the company's commitment to expanding access to advanced breast care technologies worldwide.

The HydroMARK Plus markers are part of Mammotome's comprehensive portfolio of breast biopsy site markers, offering physicians a range of choices tailored to different clinical needs. With clearance from the FDA and Health Canada, alongside the newly secured CE mark, these markers underscore Mammotome's dedication to innovation and its role as an indispensable partner to clinicians and patients in the breast care community.

Mammotome's expertise in breast care is rooted in its history and mission. As part of the Danaher Corporation since 2014, Mammotome leverages its parent company's global reach and commitment to life sciences and diagnostics innovation. Danaher's ecosystem of leading businesses works together to address complex scientific and clinical challenges, ultimately aiming to improve human health by accelerating the discovery, development, and delivery of life-changing therapies.

The availability of the HydroMARK Plus markers in Europe is expected to commence soon, with a phased rollout planned across select markets. As Mammotome continues to push the boundaries of breast care innovation, the expansion of the HydroMARK Plus markers into the European market represents a significant step forward in the fight against breast cancer, offering new hope and improved outcomes for patients and families affected by the disease.

Summary Points

01

The HydroMARK Plus Breast Biopsy Site Marker has secured a CE mark, expanding access to the technology across Europe.

02

The markers combine proprietary hydrogel technology with Wings that Cling for enhanced stability and visibility.

03

They are designed to mitigate marker displacement and provide accurate lesion localization during surgical excision.

04

The HydroMARK Plus markers are visible under ultrasound, mammography, and MRI, and are indicated for use in breast tissue and lymph nodes.

05

Mammotome's commitment to innovation and patient care is reflected in its comprehensive portfolio of breast biopsy site markers and its role as a global leader in breast care.