#Switzerland #CGM System #Basel #Continuous Glucose Monitoring #FiberSense

Introduction

FiberSense AG, based in Basel, Switzerland, has recently made significant strides in the medical technology sector by obtaining the prestigious CE marking for its Continuous Glucose Monitoring (CGM) System. This milestone not only marks a pivotal moment in the company’s journey but also represents a substantial advancement in the tools available for diabetes management.

Details of the CE Marking

The CGM System has been awarded CE designation under Regulation (EU) 2017/745 as a Class IIb medical device. This classification is crucial as it confirms the system’s compliance with EU standards for health and safety, allowing it to be marketed across various regions within the European Union. Specifically designed for adults managing diabetes, the system continuously monitors glucose levels and trends by employing advanced optical sensing technology that measures glucose concentrations from tissue fluid beneath the skin.

Innovative Features

One of the standout features of the FiberSense CGM System is its long-wear capability. Unlike conventional monitors that require frequent replacements, this system’s optical sensor and overtape can be worn comfortably for up to 28 days, significantly reducing the hassle of routine replacements. The design includes a reusable detector and charger, emphasizing its practicality for everyday use.

Company Insights

Michael Tillmann, Chairman and CEO of FiberSense AG, expressed enthusiasm about this major regulatory milestone, stating, "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 actively transitioning from the regulatory phase to commercial readiness, preparing for an expansive market entry that includes ramping up manufacturing capabilities, ensuring efficient logistics, and establishing robust customer support.

Market and Future Prospects

Looking ahead, FiberSense not only aims to distribute its CGM System but also to expand its product offerings. The current approved use focuses on continuous glucose monitoring, but the company is already planning further development in its continuous multi-analyte (CxM) sensing platform. Future targets in this pipeline include measuring ketones, lactate, and cortisol, showcasing FiberSense’s commitment to pushing the boundaries of health monitoring technology.

Conclusion

The achievement of CE marking for the FiberSense CGM System highlights a promising future for individuals living with diabetes. Emphasizing long-term health and continuous monitoring solutions, FiberSense positions itself at the forefront of innovation in medical technology. With expected initial deliveries set for late 2026, the anticipation surrounding the CGM System is both tangible and transformative for the diabetes management landscape.

For more information, you can visit FiberSense’s official website.

About FiberSense

Founded in Basel, FiberSense AG specializes in optical biomarker sensing technology aimed at enhancing health and medical solutions. Emerging from the experience of EyeSense—a spin-off from CIBA Vision, previously part of Novartis—the company seeks to innovate monitoring systems that can seamlessly integrate into daily life.