FiberSense Secures CE Mark for Optical CGM Device
FiberSense has obtained CE marking for its continuous glucose monitor (CGM) that uses optical sensor technology to measure glucose concentration in subcutaneous tissue fluid. This milestone brings the company closer to commercializing its device in Europe.
FiberSense, a developer of continuous glucose monitors (CGMs), announced it has received CE marking for its new device that uses optical sensor technology. The certification is a key step toward commercial readiness for the device, which monitors glucose concentration in the subcutaneous tissue fluid.
The Product
FiberSense's device employs fiber-optic technology to measure glucose, differentiating it from traditional CGM devices that rely on enzymatic reactions. It aims to provide accurate, continuous readings without frequent calibration.
Pricing & Availability
FiberSense has not yet disclosed pricing or a commercial launch timeline. However, the CE mark allows the company to begin sales in the European Union.
Competition
The device enters a market dominated by major players such as Abbott Laboratories (ticker: ABT) with its FreeStyle Libre and Dexcom. The company may face challenges gaining market share given the strength of incumbents.
Potential Impact on the Company
This development represents an opportunity for FiberSense to enter the growing CGM market, valued at billions of dollars. However, its success will depend on convincing healthcare providers and patients of the efficacy of its novel technology.
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