{"id":3706,"date":"2026-06-16T10:59:24","date_gmt":"2026-06-16T10:59:24","guid":{"rendered":"https:\/\/fibersense-cxm.com\/?p=3706"},"modified":"2026-06-16T12:48:06","modified_gmt":"2026-06-16T12:48:06","slug":"fibersense-cgm-ce-mark","status":"publish","type":"post","link":"https:\/\/fibersense-cxm.com\/en\/fibersense-cgm-ce-mark\/","title":{"rendered":"FiberSense Continuous Glucose Monitoring (CGM) System obtains CE mark as commercial launch preparations begin"},"content":{"rendered":"\n<p class=\"has-medium-font-size\"><strong>Major regulatory milestone paves the way for commercialization and marks first step toward FiberSense\u2019s broader CxM biomarker sensing strategy<\/strong><\/p>\n\n\n\n<p><strong>Basel, Switzerland, June 2026<\/strong> \u2013 FiberSense AG (\u201cFiberSense\u201d) today announced that the FiberSense Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017\/745 as a Class IIb medical device. The milestone marks an important step in the company\u2019s mission to make continuous biomarker sensing more accessible, more personal and easier to integrate into everyday life.<\/p>\n\n\n\n<p>The FiberSense CGM System is intended for the continuous monitoring of blood sugar levels and glucose trends in adults with diabetes. Based on advanced optical sensing technology, it measures glucose concentrations in the tissue fluid beneath the skin.<\/p>\n\n\n\n<p>\u201cThis certification is a defining milestone for FiberSense,\u201d said Michael Tillmann, Chairman &amp; CEO of FiberSense AG. \u201cAfter years of dedicated development, our focus now turns to manufacturing scale-up and commercialization.\u201d<\/p>\n\n\n\n<p><strong>Designed for long-wear glucose monitoring in daily life<\/strong><\/p>\n\n\n\n<p>Continuous glucose monitoring has become an increasingly important part of diabetes management worldwide, helping people living with the disease follow glucose values, trends and daily patterns over time. FiberSense aims to support them with practical glucose monitoring solutions designed around long wear, reusable components and easier integration into everyday life.<\/p>\n\n\n\n<p>The FiberSense CGM System combines a glucose-sensitive sensor fiber with reusable electronic components and the FiberSense App. The sensor and overtape are designed to be worn for up to 28 days before replacement, while the detector and charger have been developed for repeated use.<\/p>\n\n\n\n<p>This long-wear and reusable-component model is intended to reduce routine interruptions and support continuous glucose monitoring in daily life.<\/p>\n\n\n\n<p><strong>Commercial launch preparations underway<\/strong><\/p>\n\n\n\n<p>Following CE marking, FiberSense is now advancing the transition from regulatory certification to commercial readiness. The company is preparing manufacturing ramp-up, customer support structures and market access activities, with a series of initial orders from selected customers already confirmed.<\/p>\n\n\n\n<p>\u201cOur focus is on controlled scale-up across manufacturing, logistics and customer support as we move from CE marking to commercial execution,\u201d said Dario Clos, Chief Operating Officer of FiberSense. \u201cWith initial orders confirmed and further orders being accepted from selected customers, our priority is to build a robust launch process before first deliveries are made toward the end of 2026.\u201d<\/p>\n\n\n\n<p><strong>First regulated application of a broader CxM strategy<\/strong><\/p>\n\n\n\n<p>Continuous glucose monitoring is the first regulated application of FiberSense\u2019s planned continuous multi-analyte (\u201cCxM\u201d) platform. While the current approved intended use is continuous glucose monitoring in adults with diabetes, FiberSense continues to advance its CxM pipeline, with ketones, lactate and cortisol among the next sensor targets under evaluation.<\/p>\n\n\n\n<p>\u201cThe FiberSense CGM System represents the first regulated application of a broader long-term strategy,\u201d said Dr. Achim M\u00fcller, Chief Technology Officer of FiberSense. \u201cWe see FiberSense as an optical sensing platform with potential beyond a single analyte. Glucose monitoring is the first regulated application, but our longer-term ambition is to explore how optical sensing may support additional medical and lifestyle-oriented applications in the future, where supported by the necessary scientific, clinical and regulatory evidence.\u201d<\/p>\n\n\n\n<p><strong>Contact FiberSense<\/strong><\/p>\n\n\n\n<p>media@fibersense-cxm.com<br>+49 (0)6026 942 121<br><a href=\"http:\/\/www.fibersense-cxm.com\">www.fibersense-cxm.com<\/a><\/p>\n\n\n\n<p><strong>About FiberSense<\/strong><\/p>\n\n\n\n<p>FiberSense AG is an optical biomarker sensing company headquartered in Basel, Switzerland. Building on the experience of EyeSense, a spin-off from CIBA Vision, formerly part of the Novartis Group, FiberSense combines optical sensing expertise with the ambition to develop practical, low-maintenance and more sustainable monitoring solutions. The company\u2019s first regulated application is the CE-marked FiberSense Continuous Glucose Monitoring (CGM) System for continuous glucose monitoring in adults with diabetes. At the same time, FiberSense is advancing its broader continuous multi-analyte (\u201cCxM\u201d) biomarker sensing platform, with the aim of exploring future opportunities beyond glucose, including additional metabolic and lifestyle-related signals.<\/p>\n\n\n\n<p><strong>Regulatory and forward-looking note<\/strong><\/p>\n\n\n\n<p>The FiberSense CGM System is a CE-marked Class IIb medical device under Regulation (EU) 2017\/745 and is intended for continuous glucose monitoring in adults with diabetes in accordance with the Instructions for Use. Product availability remains subject to applicable regulatory, quality, manufacturing, commercial and market-specific requirements.<\/p>\n\n\n\n<p>This release contains forward-looking statements, including statements regarding commercialization timelines, first deliveries, manufacturing ramp-up, market access, international expansion and future biomarker sensing applications. Actual timing, availability, product features, regulatory status and commercial outcomes may differ materially. Future applications beyond the current approved intended use of the FiberSense CGM System will be pursued only where supported by appropriate scientific, technical, clinical and regulatory evidence.<\/p>\n\n\n\n<div class=\"wp-block-buttons is-layout-flex wp-block-buttons-is-layout-flex\">\n<div class=\"wp-block-button is-style-outline is-style-outline--1\"><a class=\"wp-block-button__link has-white-color has-text-color has-background has-link-color wp-element-button\" href=\"https:\/\/fibersense-cxm.com\/wp-content\/uploads\/2026\/06\/260615-FiberSense-MDR-CE-Cert.pdf\" style=\"background-color:#00a86b\" target=\"_blank\" rel=\"noreferrer noopener\">CE-Certificate download<\/a><\/div>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Major regulatory milestone paves the way for commercialization and marks first step toward FiberSense\u2019s broader CxM biomarker sensing strategy Basel, Switzerland, June 2026 \u2013 FiberSense AG (\u201cFiberSense\u201d) today announced that the FiberSense Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017\/745 as a Class IIb medical device. The milestone marks an [&hellip;]<\/p>\n","protected":false},"author":10,"featured_media":3253,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-3706","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FiberSense Continuous Glucose Monitoring (CGM) System obtains CE mark as commercial launch preparations begin - FiberSense Gmbh \u2013<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/fibersense-cxm.com\/en\/fibersense-cgm-ce-mark\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"FiberSense Continuous Glucose Monitoring (CGM) System obtains CE mark as commercial launch preparations begin - FiberSense Gmbh \u2013\" \/>\n<meta property=\"og:description\" content=\"Major regulatory milestone paves the way for commercialization and marks first step toward FiberSense\u2019s broader CxM biomarker sensing strategy Basel, Switzerland, June 2026 \u2013 FiberSense AG (\u201cFiberSense\u201d) today announced that the FiberSense Continuous Glucose Monitoring (CGM) System has obtained CE marking under Regulation (EU) 2017\/745 as a Class IIb medical device. 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