Abbott Secures CE Mark for World's First Dual Glucose-Ketone Continuous Monitoring Device
Abbott Laboratories has received CE Mark approval in Europe for a continuous monitoring device that simultaneously measures both glucose and ketone levels, a world first that extends Abbott's CGM franchise beyond diabetes management and into broader metabolic health monitoring.
A First-in-Class Metabolic Device
Abbott Laboratories has received CE Mark approval in Europe for a device capable of simultaneously and continuously measuring both blood glucose and ketone levels, a combination that no commercially available continuous monitoring product has offered before. The approval builds on Abbott's dominant FreeStyle Libre franchise, which has become the world's most widely used continuous glucose monitoring system with over 6 million active users.
Traditional continuous glucose monitors track blood sugar levels and are primarily used by people managing diabetes. Adding continuous ketone monitoring to the same sensor opens a second market: the growing population of people following ketogenic diets, athletes optimising performance through metabolic state management, and people with type 1 diabetes where diabetic ketoacidosis is a serious medical risk.
Why This Matters for Abbott
CGM is one of the fastest-growing segments in medical devices. Abbott's FreeStyle Libre competes directly with Dexcom's G-series monitors, and pricing competition has been a feature of the category. A first-in-class dual sensing device creates differentiation that is difficult for competitors to replicate quickly, as it requires a fundamentally different sensor chemistry validated to the same accuracy standards as glucose-only devices.
CE Mark approval covers the European market. A separate US FDA clearance process will determine when and if the device can be commercialised in North America, which is Abbott's largest single market for CGM products.
Goldman Sachs Reaffirms Buy
Goldman Sachs maintained its Buy rating on Abbott around the same period, citing the company's diversified medical device and diagnostics portfolio as undervalued relative to peers. Abbott also declared its 410th consecutive quarterly dividend during the quarter, underscoring the consistency of its capital returns programme.
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Frequently asked questions
What is CE Mark?
CE Mark is the European regulatory approval for medical devices, indicating conformity with EU safety and performance standards. It allows the device to be sold across the European Economic Area.
Who competes with Abbott in CGM?
Dexcom is Abbott's primary competitor in continuous glucose monitoring, with its G7 device competing directly against the FreeStyle Libre 3. The dual glucose-ketone capability is not yet available in any Dexcom product.
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