FiberSense has obtained a CE mark for its continuous glucose monitoring (CGM) system, setting the stage for the medical device’s commercialisation in Europe.
As with other CGMs, FiberSense’s system is designed for the continuous monitoring of blood glucose levels and glycaemic trends in adults with diabetes. Comprised of an optical sensor and an external detector clip that can be worn for up to 28 days, the company’s device measures glucose concentrations in the subcutaneous tissue fluid and displays them on a paired smartphone app.
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Popular CGM products from Dexcom and Abbott use electrochemical sensors and are worn for shorter periods. Senseonics’s Eversense 365 lasts up to a year but requires implantation, meaning FiberSense’s technology offers a time period in between the two.
FiberSense CEO, Michael Tillman, commented: “After years of intensive development, we are now focusing on scaling up production and commercialisation.”
In moving towards commercial readiness, FiberSense highlighted that this will be achieved by focusing on scaling up its production, logistics, customer service, and market access activities for selected launch markets, with the device’s first deliveries to customers anticipated by the end of 2026.
The CE mark for FiberSense’s device in diabetes represents the first regulated application of the continuous multi-analysis (CxM) platform the company plans to develop. FiberSense shared that it intends to advance its product portfolio in future with ketones, lactate, and cortisol among the next sensors currently under evaluation.
Tillman explained: “The FiberSense CGM system represents the first regulated application of our long-term strategy. The goal is to explore additional opportunities in continuous biomarker detection beyond glucose and develop a platform that could one day support other assays and applications, provided it has the necessary scientific, clinical, and regulatory evidence.”
GlobalData analysis reveals that the global CGM market is growing at a CAGR of 9.8% and is projected to reach a valuation of around $15.7bn in 2035. The European CGM market is dominated by Abbott. The company held a European market share of 76.8% in 2025, as per a GlobalData market model.
FiberSense’s CE mark follows a significant milestone for diabetes specialist Dexcom on the US market. On 12 June, the US Food and Drug Administration (FDA) cleared Dexcom’s Stelo glucose biosensor system for children, making it the first over-the-counter (OTC) CGM for paediatric prediabetic and diabetic patients to be cleared by the agency.
