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FiberSense Secures CE Mark for Long-Wear Glucose Monitor

Basel-based FiberSense AG has received CE marking for its Class IIb continuous glucose monitoring system, marking a critical step toward the commercial rollout of its optical sensing technology. The device, designed for adults with diabetes, is the first regulated product from the company’s broader biomarker sensing platform.

FiberSense Secures CE Mark for Long-Wear Glucose Monitor

The system utilizes advanced optical sensors to track glucose concentrations in interstitial tissue fluid. A key differentiator in the design is the 28-day wear time for the sensor and overtape, a significant extension compared to many current market alternatives. The detector and charger components are built for repeat use, aiming to reduce the frequency of routine replacements for patients.

Michael Tillmann, Chairman and CEO, confirmed that the company is shifting its focus toward manufacturing scale-up and logistics. With initial orders already confirmed, FiberSense expects to begin first deliveries by late 2026. This regulatory approval validates the company's long-term strategy to develop a multi-analyte platform, known as CxM, which aims to eventually monitor additional biomarkers such as ketones, lactate, and cortisol.

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