This morning Abbott announced that its continuous glucose monitor the FreeStyle Libre 3 earned a CE mark, making it cleared for use for individuals with diabetes living in the European Union. This news comes just a few months after the company landed the much-awaited U.S. FDA clearance for its FreeStyle Libre 2.
Like its predecessor this monitor can also last for 14 days and transmit glucose data to a users’ smartphone every minute. This latest version is smaller than previous versions –about the size of two stacked U.S. pennies, according to the company. Users apply the one-piece applicator to the back of the upper arm. The technology is also able to give users alerts and trends data via their smartphone app.
This new design marks the first time that the company has changed the design since launching the original FreeStyle Libre. Because the technology is smaller than previous versions, the company said that it is better for the environment.
While the technology is not yet available in the U.S., according to an Abbott spokesperson the company is planning to roll out the technology in other markets pending regulatory approval. The company said that it will price the new product at the same price point as the last version of the device.
WHY IT MATTERS
According to the World Health Organization, there are 60 million people in Europe with diabetes. That number is growing, according to the agency, who attributes the uptick to obesity, unhealthy diet and physical inactivity. The company is pitching this tool as a convenient way for those living with the disease to monitor it.
"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 for diabetes care at 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."
THE LARGER TREND
Within the last month Abbott has had its sights set on the European market. Earlier this month it announced that its Libre Sense Glucose Sport Biosensor earned a CE Mark. The Libre Sense was designed to help athletes understand the efficacy of their nutrition choices on training and competition.
In 2017 Abbott’s Freestyle Libre system became the first CGM to be FDA cleared for use without fingerstick. At the time, the system was cleared for 10-day use, but in 2018 Abbott got another clearance for its FreestyleLibre 14 Day Flash Glucose Monitoring System.
In June, the med tech company got the FDA greenlight for its FreeStyle Libre 2 to be used by adults and kids over the age of 4 with diabetes.