April 25, 2025 – Carbon Medical Technologies, Inc. (CMT), a manufacturer of pyrolytic carbon-coated
medical devices used in biopsy procedures, for radiation therapy, and to treat stress urinary incontinence, is
proud to announce that our BiomarC Tissue Marker System has successfully achieved certification under the
European Union Medical Device Regulation (EU MDR 2017/745). This certification underscores our
commitment to meeting the highest standards of safety, performance, and clinical efficacy required by the
European Union for medical devices. The EU MDR certification is recognized globally for its stringent
requirements, ensuring that medical devices meet rigorous standards for quality and safety. With this
certification, our BiomarC Tissue Markers are authorized to carry the CE marking under the new regulation,
facilitating their continued availability across European markets.
BiomarC Tissue Markers are designed to mark biopsy sites within breast tissue, supporting accurate
localization during follow-up imaging and procedures. Each marker is composed of a natural, non-metallic
pyrolytic carbon coating that is clearly visible under ultrasound, mammography, CT, CBCT, fluoroscopy, and
MRI—with minimal imaging artifacts. The unique marker shape enhances visibility and placement accuracy,
and the markers are preloaded into delivery systems compatible with both vacuum-assisted and core needle
biopsy devices. With a range of sizes and gauge options, BiomarC Tissue Markers offer physicians flexibility
and precision in breast biopsy site marking.
Achieving this milestone reflects the dedication and hard work of our entire team, who have diligently
worked to align our products with the comprehensive requirements of the EU MDR. We remain committed
to providing innovative and reliable solutions that enhance patient care and support healthcare professionals
worldwide.
For more information about CMT’s BiomarC Tissue Marker System, please visit www.carbonmed.com or
contact 1-888-207-0262.
About Carbon Medical Technologies, Inc.
Carbon Medical Technologies, Inc. (CMT) is a privately held company formed in 1994 to design, develop,
and manufacture implantable medical devices that utilize a pyrolytic carbon-coating technology. CMT
operates a fully functional pyrolytic carbon coating facility and has developed multiple FDA approved,
cleared to market, and CE Marked products. Currently, the pyrolytic carbon coating technology is
incorporated into BiomarC Tissue Markers developed for biopsy site marking, the BiomarC Fiducial Marker
Product Line for radiation therapy treatment planning, and an injectable bulking agent called Durasphere,
which is used for the treatment of stress urinary incontinence in women. CMT also provides product
development, contract manufacturing, and regulatory consulting for medical device companies. The
company is a medical device manufacturer with ISO 13485 certified and cGMP compliant quality systems,
maintains three different sterilization method validations, and does final product assembly and packaging in
an ISO Class 7 clean room environment.
April 25, 2025