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Key regulatory milestone paves the way for commercialization, marking the first step toward a broader CxM biomarker sensing strategy
Basel, SwitzerlandJune 22, 2026 /PRNewswire/ — FiberSense AG (“FiberSense”) today announced that its continuous glucose monitoring (CGM) system has obtained CE marking under EU Regulation (EU) 2017/745 as a Class IIb medical device.
FiberSense obtains CE marking for its new CGM System, designed to support continuous glucose monitoring in everyday life
The system is intended for continuous monitoring of glucose levels and glucose trends in adult patients with diabetes. Based on advanced optical sensing technology, it measures glucose concentration in the interstitial fluid beneath the skin.
To support longer wear time and reduce routine replacements, the system’s optical sensor and adhesive tape can be worn for up to 28 days before replacement, while the detector and charger are designed for reuse.
“This certification is a defining milestone for FiberSense,” said Michael Tillmann, Chairman and CEO of FiberSense AG. “After years of focused development, our focus now shifts to manufacturing scale-up and commercialization.”
With the CE marking achieved, FiberSense is advancing the transition from regulatory certification to commercial readiness. The company is preparing manufacturing upgrades, logistics, customer support, and market access activities for selected launch markets, with initial orders already confirmed and first deliveries expected by the end of 2026.
Continuous glucose monitoring is the first specific application of FiberSense’s planned continuous multi-analyte (“CxM”) platform. While the currently approved intended use is for continuous glucose monitoring in adult patients with diabetes, FiberSense continues to advance its CxM pipeline, with ketones, lactate, and cortisol as the next sensor targets under evaluation.
“The FiberSense CGM system is the first specific application of our long-term strategy,” Tillmann commented. “Our goal is to explore additional opportunities for continuous biomarker detection beyond glucose and develop a platform solution that, supported by the necessary scientific, clinical, and regulatory evidence, could one day support other analytes and applications.”
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About FiberSense
FiberSense AG, headquartered in Basel, Switzerland, is an optical biomarker sensing company focused on health and medical technology. Building on the experience of EyeSense, a spin-off from CIBA Vision (formerly part of Novartis), FiberSense combines optical sensing expertise with the ambition to develop innovative long-wear monitoring solutions for everyday use.
Regulatory and Forward-Looking Statements
The FiberSense CGM system is a CE-marked Class IIb medical device under Regulation (EU) 2017/745, intended for continuous glucose monitoring in adult patients with diabetes in accordance with the instructions for use. Beyond glucose, product availability, first deliveries, and future applications remain subject to applicable regulatory, quality, manufacturing, commercial, and market-specific requirements.