FiberSense Gets CE Mark for 28-Day CGM; LifeScan Partners With i-SENS, Names New CEO
FiberSense received CE marking for its optical CGM system with up to 28-day wear, while LifeScan partnered with i-SENS to launch the OneTouch Vita CGM and appointed a new CEO. Senseonics' year-long Eversense 365 implantable CGM is also detailed.
FiberSense has received CE marking for its continuous glucose monitoring (CGM) system, which uses advanced optical sensing technology to measure glucose concentrations in the interstitial fluid. With the CE mark in hand, FiberSense said it now plans to advance its transition from regulatory certification to commercial readiness, and has confirmed initial orders with first deliveries expected in late 2026.
The FiberSense system is intended for the continuous monitoring of blood sugar levels and glucose trends in adults with diabetes. It designed the sensor and overtape for use of up to 28 days before replacement, approximately doubling the wear time of currently available sensors that measure interstitial fluid, such as the sensors from Abbott, Dexcom and Roche. Glucose monitoring marks the first regulated application of FiberSense's planned multi-analyte (CxM) platform, with ketones, lactate and cortisol monitoring under evaluation. Abbott recently won CE mark for a dual glucose-ketone sensor, and Dexcom plans to add multi-analyte sensing to its next-generation G8 platform.
LifeScan announced a partnership with i-SENS, a global in vitro diagnostics company, to launch a continuous glucose monitoring (CGM) system under the OneTouch Vita brand. The company and i-SENS expect to launch the continuous glucose monitoring products in Germany, Ireland, Portugal, and Belgium by early 2027, with plans to expand into additional markets over time. LifeScan said there are no changes across the rest of the OneTouch portfolio in connection with this announcement. More than 20 million people and their caregivers around the world count on LifeScan's OneTouch brand products to manage their diabetes.
LifeScan also appointed a new CEO, effective immediately. The new CEO succeeds the co-CEOs who served in an interim capacity since January 2026, following the retirement of the longtime CEO. He joins with more than two decades of experience leading global healthcare, life sciences and medtech companies. Most recently, he served as CEO of a laboratory distribution business that was transformed into a global life sciences and bioprocessing platform, and previously held senior leadership roles at two medical product companies. LifeScan plans for one of the outgoing interim co-CEOs to continue as board chair, while the other remains EVP and CFO. LifeScan develops the OneTouch Bluetooth-connected blood glucose meter and mobile diabetes app.
Senseonics launched its Eversense 365 implantable CGM in 2024. The device rests under the skin for a year, and users can change its external, silicone-based adhesive daily with almost no skin reactions. Eversense 365 is an integrated CGM (iCGM) system, meaning it can work with compatible medical devices, including insulin pumps as part of automated insulin delivery systems. Senseonics launched its system with the Sequel Med Tech twiist pump earlier this year.