FiberSense has received CE mark approval for its continuous glucose monitoring (CGM) system, allowing the company to move toward commercialization in selected European markets.
The CGM uses optical sensing technology to continuously measure glucose levels in interstitial fluid for adults with diabetes. The company says its sensor and adhesive system are designed for up to 28 days of wear, potentially reducing the frequency of sensor replacement compared with many existing CGM devices.
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With regulatory approval secured, FiberSense plans to scale manufacturing, prepare market access, and begin initial deliveries expected in late 2026.
CEO Michael Tillmann 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 glucose monitoring system is the first regulated application of FiberSense’s broader multi-analyte sensing platform, with future potential applications including monitoring biomarkers such as ketones, lactate, and cortisol.
