Carbon Medical Technologies’ InjecSURE® Injection System Receives FDA 510(k) Clearance, Expanding CMT’s Portfolio of Urology Delivery Solutions

Saint Paul, MN - April 15, 2026. Carbon Medical Technologies, Inc. (CMT), a manufacturer of implantable medical devices and delivery systems utilizing proprietary technologies, is pleased to announce that its InjecSURE® Injection System has received clearance from the U.S. Food and Drug Administration (FDA) through the 510(k) pathway. This milestone marks the introduction of a new accessory system designed to support the delivery of syringe-based injectable materials into urethral tissues during cystoscopic procedures.

The InjecSURE® Injection System is intended for use as an accessory to currently marketed cystoscopes. The system includes sterile, single-use components for one patient, featuring a disposable sheath and a 20-gauge, 5-inch (127 mm) injection needle, available in both pencil-point and spinal tip configurations.

"This FDA clearance represents an important step forward in expanding our portfolio of solutions that support physicians in delivering injectable therapies with precision and confidence," said Stephanie Kent, President and CEO of Carbon Medical Technologies. "We are proud to introduce the InjecSURE® Injection System as part of our ongoing commitment to developing practical, clinically relevant tools that integrate seamlessly into existing procedures and workflows. InjecSURE® reflects our close collaboration with clinicians and was designed to support a more intuitive and consistent delivery experience."

The disposable sheath is compatible with 2.7 mm cystoscopes of various lengths and is designed to attach securely to the cystoscope, providing a guided pathway for the injection needle to reach the desired location. The system incorporates multiple design features to support procedural workflow, including irrigation fluid ports compatible with standard gravity-fed irrigation systems, self-sealing silicone needle ports to minimize fluid leakage, and a locking collar to secure the sheath to the cystoscope. A tapered, atraumatic tip is designed to aid insertion, and the dual needle-port configuration provides a non-rotatable design to support consistent positioning.

InjecSURE® Injection Needles utilize a standard luer-lock syringe connection, enabling connection to syringe-based injectable materials. As such, the system is compatible with injectable materials supplied in standard luer-lock syringes, including bulking agents.

The InjecSURE® Injection System will be offered through flexible purchasing options, allowing healthcare providers to align product selection with their procedural preferences and existing supply workflows.

The InjecSURE® Injection System will be available for commercial use in the United States following initial production release. Carbon Medical Technologies will continue to work closely with clinicians to support adoption and gather feedback as the system is introduced into practice.

For more information about the InjecSURE® Injection System, please visit www.carbonmed.com or contact 1-888-207-0262.

Carbon Medical Technologies, Inc. (CMT) is a privately held company founded in 1994 to design, develop, and manufacture implantable medical devices and delivery systems utilizing proprietary pyrolytic carbon-coating technology. CMT operates a fully functional coating facility and has developed multiple FDA-approved, FDA-cleared, and CE Marked products. This technology is incorporated into the BiomarC Tissue Marker System for biopsy site localization, the BiomarC Fiducial Marker Product Line for radiation therapy treatment planning, and Durasphere®, an injectable bulking agent used in 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 multiple validated sterilization methods, and performs final assembly and packaging in an ISO Class 7 clean room environment.

Carbon Medical Technologies, Inc. | 1290 Hammond Rd, Saint Paul, MN 55110 | 651-653-8512