#diabetes management #Switzerland #CGM System #Basel #FiberSense

FiberSense Advances Diabetes Care with New CGM System

In a significant breakthrough for diabetes management, FiberSense AG, based in Basel, Switzerland, has announced the achievement of CE marking for its Continuous Glucose Monitoring (CGM) System. This important certification, announced on June 17, 2026, signifies that the system meets stringent European standards as a Class IIb medical device under Regulation (EU) 2017/745. The CGM System is designed for ongoing monitoring of blood glucose levels in adults living with diabetes.

The FiberSense CGM System employs cutting-edge optical sensing technology to provide real-time monitoring of glucose concentrations in interstitial fluid beneath the skin. One of the most compelling features of this system is its ability to be worn for an impressive duration of up to 28 days without the need for routine replacements. This is made possible thanks to its innovative optical sensor and overtape design, offering patients a more convenient and user-friendly experience when compared to traditional monitoring methods that often require more frequent changes.

Michael Tillmann, Chairman and CEO of FiberSense, emphasized the significance of this CE marking in the company’s journey. He stated, "This certification is a defining milestone for FiberSense. After years of dedicated development, our focus now turns to manufacturing scale-up and commercialization." With the CE marking secured, FiberSense is swiftly transitioning from regulatory certification towards operational readiness for commercial sale. The company is currently ramping up manufacturing processes, strengthening logistics, and building customer support infrastructure aimed at select launch markets.

Notably, initial orders have already been confirmed, with the first deliveries anticipated in late 2026. This move marks the beginning of a broader strategy for FiberSense—building on the success of the CGM System as the foundation for a continuous multi-analyte (CxM) platform. While the current application focuses on glucose monitoring, the company has plans to expand its sensor capabilities to include the measurement of ketones, lactate, and cortisol in the near future.

Tillmann commented on the ambitious scope of FiberSense’s vision for the future. He stated, "The FiberSense CGM System represents the first regulated application of our long-term strategy. 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." This progressive approach underlines FiberSense’s commitment to using innovative technology to empower individuals living with chronic conditions, providing them with easier management of their health.

Operating out of Switzerland, FiberSense specializes in optical biomarker sensing technologies and is a spin-off of EyeSense, a company born out of CIBA Vision, associated with Novartis. With a strong emphasis on health and medical technology, FiberSense seeks to integrate advanced optical sensing expertise to devise long-wearing monitoring solutions suitable for daily life.

As they pursue this exciting transition from development to commercialization, FiberSense will remain accountable to the necessary scientific, clinical, and regulatory evidence needed to expand their offerings and ensure the highest standards of quality and care for their users. As the FiberSense Continuous Glucose Monitoring System prepares to hit the market, stakeholders and patients alike are watching closely, for it promises not only to enhance diabetes management but also to set the stage for the future of personalized healthcare.