Major regulatory milestone paves the way for commercialization and marks first step toward broader CxM biomarker sensing strategy
BASEL, Switzerland, June 17, 2026 /PRNewswire/ -- FiberSense AG ("FiberSense") today announced that the FiberSense 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 the 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 have been designed for repeat use.
"This certification is a defining milestone for FiberSense," said Michael Tillmann, Chairman & CEO of FiberSense AG. "After years of dedicated development, our focus now turns to manufacturing scale-up and commercialization."
With CE marking achieved, FiberSense is now advancing the transition from regulatory certification to commercial readiness. The company is preparing manufacturing ramp-up, logistics, customer support and market access activities for selected launch markets, with initial orders already confirmed and first deliveries expected in late 2026.
Continuous glucose monitoring is the first regulated application of FiberSense's planned continuous multi-analyte ("CxM") platform. While the current approved intended use is continuous glucose monitoring in adults with diabetes, FiberSense continues to advance its CxM pipeline, with ketones, lactate and cortisol among the next sensor targets under evaluation.
"The FiberSense CGM System represents the first regulated application of our long-term strategy," Tillmann commented. "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."
Contact FiberSense
+49 (0)6026 942 121
media@fibersense-cxm.com
www.fibersense-cxm.com
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 note
The FiberSense CGM System is a CE-marked Class IIb medical device under Regulation (EU) 2017/745 and is intended for continuous glucose monitoring in adults with diabetes in accordance with the Instructions for Use. Product availability, first deliveries and future applications beyond glucose remain subject to applicable regulatory, quality, manufacturing, commercial and market-specific requirements.
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