Product News: Abbott's FreeStyle Libre 3 System receives CE Mark

Abbott, have announced that they have secured CE Mark (Conformité Européenne) for their next-generation FreeStyle Libre 3 system, which is now approved for use by people living with diabetes in Europe. The FreeStyle Libre 3 technology is designed to provide continuous, real-time glucose readings automatically delivered to smartphones every minute, offering unsurpassed 14-day accuracy in the smallest and thinnest sensor design at the same affordable price as previous versions of the device.

"Abbott won't stop innovating when there's room to raise the bar. We've done that again with FreeStyle Libre 3, the smallest sensor that delivers life-changing benefits and best-in-class accuracy," said Jared Watkin, senior vice president, Diabetes Care, Abbott. "People living with diabetes are at the center of our design process, and we made our next-generation technology even more discreet for a better user experience to make managing diabetes as easy and seamless as possible."

With a 14-day wear time, the FreeStyle Libre 3 system includes the longest-lasting, self-applied CGM sensor available. The sensor is easy to apply5 with a one-piece applicator and is worn on the back of the upper arm, eliminating the need for painful fingersticks to view glucose levels. 

To allow as many people as possible living with diabetes to access and benefit from the significant advancements of the technology, Abbott's FreeStyle Libre 3 system will be priced the same as previous generations of the device.

"Since we launched the first disposable glucose sensor in 2014, we've always believed all people with diabetes should have access to high-quality, accurate and affordable diabetes technologies," said Watkin. "That's why Abbott disrupted the traditional notion that CGMs have to sacrifice quality or accuracy for affordability, and we built our FreeStyle Libre family of products to deliver unparalleled results at a lower cost than any other CGM available." 

The FreeStyle Libre 3 system fits seamlessly into the lives of people with diabetes. In addition to the sensor, the system includes the FreeStyle Libre 3 mobile app, which is designed to enable users to capture and view their real-time glucose levels, glucose history and trend arrows showing how their glucose is changing with just a glance at their smartphone. 

Abbott designed its next-generation FreeStyle Libre 3 system to be more sustainable for the environment with a smaller and more discreet sensor, reducing the total volume by more than 70%. With a 41% reduction in plastic use and 43% reduction in carton paper, the new sensor design aligns with the company's continued commitment to sustainability.

Abbott is launching the FreeStyle Libre 3 system in Europe in the coming months. The FreeStyle Libre portfolio has been clinically proven to improve glucose control, increase time in target glucose range, decrease time in hyperglycemia (high glucose levels) and hypoglycemia (low glucose levels), and lower HbA1c (average glucose levels over a three-month period)– all factors contributing to better health outcomes. Data also show use of the FreeStyle Libre system reduces diabetes-related hospital admissions and work absentee rates to help improve quality of life.

As the #1 sensor-based glucose monitoring system used in the U.S. and worldwide, Abbott's FreeStyle Libre portfolio has changed the lives of more than 2 million people across more than 50 countries5 by providing breakthrough technology that is accessible and affordable. Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 37 countries, including Canada, France, Germany, Japan, the United Kingdom and the U.S. 

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