FiberSense Receives CE Mark for its New CGM System

FiberSense has announced that its Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017/745 as a Class IIb medical device. The system is intended for continuous monitoring of blood sugar levels and glucose trends in adults with diabetes.

Based on advanced optical sensing technology, it measures glucose concentrations in the tissue fluid beneath the skin. To support longer wear and reduce routine replacements, the system’s optical sensor and overtape can be worn for up to 28 days before replacement, while the detector and charger are designed for repeat use.

With CE marking achieved, FiberSense is now advancing from regulatory certification to commercial readiness. The Switzerland-based company is preparing manufacturing ramp-up, logistics, customer support, and market access activities for selected launch markets. Initial orders have already been confirmed, with first deliveries expected in late 2026. Michael Tillmann, Chairman and Chief Executive Officer of FiberSense, said the certification is a defining milestone for the company and that after years of dedicated development, the focus now turns to manufacturing scale-up and commercialization.

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