Switzerland-based optical biomarker sensing company FiberSense AG has received CE marking for its FiberSense Continuous Glucose Monitoring (CGM) System under Regulation (EU) 2017/745 as a Class IIb medical device.
According to the company, the system is intended for continuous monitoring of blood sugar levels and glucose trends in adults with diabetes. Using advanced optical sensing technology, it measures glucose concentrations in the tissue fluid beneath the skin.
Designed to reduce frequent replacements, the system’s optical sensor and overtape can be worn for up to 28 days before replacement, while the detector and charger are intended for repeated use.
Following regulatory approval, FiberSense is moving toward commercial readiness, focusing on manufacturing ramp-up, logistics, customer support and market access activities for selected launch markets. The company said initial orders have already been secured, with first deliveries expected in late 2026.
Michael Tillmann, Chairman & CEO of FiberSense AG, said, “This certification is a defining milestone for FiberSense. After years of dedicated development, our focus now turns to manufacturing scale-up and commercialisation.”
The CGM system marks the first regulated application of FiberSense’s planned continuous multi-analyte (CxM) platform. While the currently approved use is glucose monitoring in adults with diabetes, the company is also evaluating additional sensor targets, including ketones, lactate and cortisol.
“The FiberSense CGM System represents the first regulated application of our long-term strategy,” Tillmann said.
“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,” he added.
Building on expertise developed through EyeSense, a spin-off from CIBA Vision, formerly part of Novartis, FiberSense aims to develop innovative, long-wear monitoring solutions for everyday use.
