The FiberSense system is intended for the continuous monitoring of blood sugar levels and glucose trends in adults with diabetes. It uses advanced optical sensing technology to measure glucose concentrations in the tissue fluid beneath the skin (interstitial fluid).
FiberSense says its CGM platform supports longer wear time and reduces routine replacements. It designed the sensor and overtape for use of up to 28 days before replacement. This approximately doubles the wear time of currently available sensors that measure interstitial fluid, such as the sensors from Abbott, Dexcom and Roche.
With CE mark in hand, FiberSense said it now plans to advance its transition from regulatory certification to commercial readiness. It has plans to prepare its manufacturing ramp-up, logistics, customer support and market access activities for select markets. The company already confirmed initial orders and expects its first deliveries in late 2026.
Glucose monitoring marks the first regulated application of FiberSense’s planned multi-analyte (CxM) platform. It also intends to advance the pipeline with ketones, lactate and cortisol monitoring under evaluation. This is in line with other leading sensor makers, as Abbott recently won CE mark for a dual glucose-ketone sensor and Dexcom plans to add multi-analyte sensing to its next-generation G8 platform.
Michael Tillmann, chair & CEO of FiberSense, said:
“This certification is a defining milestone for FiberSense. After years of dedicated development, our focus now turns to manufacturing scale-up and commercialization. The FiberSense CGM System represents the first regulated application of our long-term strategy. The goal is to explore additional opportunities in continuous biomarker sensing beyond glucose and develop a platform solution that may one day support additional analytes and applications, provided it is supported by the necessary scientific, clinical and regulatory evidence.”
