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Explore the futureof continuous sensing.

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Stockstädter Str. 17, 63762 Großostheim, DE

Stockstädter Str. 17, 63762 Großostheim, DE

+49 (0) 6026 942 0

+49 (0) 6026 942 0

+49 (0) 6026 942 126

+49 (0) 6026 942 126

info@FiberSense-cxm.com

info@fibersense-cxm.com

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The FiberSense CGM System is a Class IIb CE-marked medical device in accordance with Regulation (EU) 2017/745. It is intended as a continuous glucose monitoring system for continuous measurement at home in adults with diabetes. The system measures glucose concentrations in interstitial fluid and supports the monitoring of blood glucose levels and glucose trends as part of diabetes self-management. The FiberSense CGM System must only be used in accordance with the instructions for use. Contraindications, warnings, precautions, calibration requirements, smartphone compatibility requirements, protection ratings, and other restrictions must be observed. The system is not intended for use in children or adolescents under 18 years of age or during pregnancy. Users should consult healthcare professionals regarding individual decisions in diabetes management and use a blood glucose meter when required by the instructions for use. Treatment decisions are the responsibility of the user and/or healthcare professionals and should be made in accordance with the instructions for use, clinical advice, and—where necessary—blood glucose readings. The FiberSense app is designed as part of the FiberSense CGM system and does not provide standalone diagnoses, treatment recommendations, or automated treatment management. The sensor is designed to be worn for up to 28 days. When the detector is properly attached to the sensor, the detector and base plate form a protected connection; the applicable protection rating is described in the instructions for use. Clinical and performance data supporting the intended use, wear time, and product specifications are available upon request, as appropriate, including study design, study population, endpoints, comparator information, accuracy metrics, and limitations.

Product
Company
- Noovia by FiberSense
- For investors
Career
News

Product
Company
- Noovia by FiberSense
- For investors
Career
News

DE
EN

Product
Company
- Noovia by FiberSense
- For investors
Career
News

Product
Company
- Noovia by FiberSense
- For investors
Career
News