Carbon Medical Technologies’ BiomarC Fiducial Markers and BiomarC Restore Achieves EU MDR Certification
August 8, 2025 – Carbon Medical Technologies, Inc. (CMT), a manufacturer of implantable medical devices that utilize proprietary pyrolytic carbon coating technology, is proud to announce that both its BiomarC Fiducial Marker Product Lineand BiomarC Restore have successfully achieved certification under the European Union Medical Device Regulation (EU MDR 2017/745). These certifications underscore CMT’s continued commitment to delivering safe, effective, and innovative devices for use in radiation oncology, diagnostic imaging, and soft tissue marking.
BiomarC Fiducial Markers act as radiographic landmarks, making it easier for clinicians to locate the tumor before and during radiation. The product line includes both pyrolytic carbon-coated fiducialsandgold fiducial options, offering clinicians flexibility in marker selection based on patient-specific imaging needs. BiomarC fiducials are visible under CT, CBCT, MRI, and ultrasound. Clinical applications include use in the prostate, breast, and other soft tissue targets.
BiomarC Restore is a specialized fiducial marker developed specifically for lumpectomy cavity marking following breast-conserving surgery. It is intended to replace resected tissue to provide the lumpectomy cavity with long-term radiographic visibility to support post-operative treatment planning and delivery. BiomarC Restore’s certification as a unique product under EU MDR reflects its differentiated use case and growing adoption among breast surgeons and radiation oncologists.
EU MDR certification is recognized globally for its stringent requirements governing device safety, quality systems, risk management, and post-market surveillance. With this designation, BiomarC Fiducial Markers and BiomarC Restoreare now authorized to carry the CE mark under the new regulation, supporting continued availability in European markets. Achieving these certifications reflects the dedication of our regulatory, quality, and engineering teams, who have worked diligently to align our products with the latest European standards. We remain committed to advancing solutions that improve procedural precision and clinical outcomes across oncology care.
For more information about CMT’s BiomarC Fiducial Marker Product Line, 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 founded in 1994 to design, develop, and manufacture implantable medical devices using proprietary pyrolytic carbon-coating technology. CMT operates a fully functional coating facility and has developed multiple FDA-approved, CE Marked products. This technology is incorporated into BiomarC Tissue Markers for biopsy site localization, the BiomarC Fiducial Marker Product Line for radiation treatment planning, and Durasphere, an injectable bulking agent for the treatment of stress urinary incontinence in women. In addition to its product portfolio, CMT provides product development, contract manufacturing, and regulatory consulting services. The company maintains ISO 13485 certified and cGMP compliant quality systems, supports three validated sterilization methods, and performs final assembly and packaging in an ISO Class 7 clean room environment.