Abbott finally gets FDA greenlight for FreeStyle Libre 2

The system is able to continuously transmit glucose data every minute.
By Laura Lovett
03:15 pm

This morning Abbott revealed that its much anticipated integrated continuous glucose monitoring system the FreeStyle Libre 2 is now FDA cleared for adults and kids over the age of 4 with diabetes. 

The latest product is able to continuously transmit glucose data every minute, and users can set the system to send alarms when their glucose is too high or too low. Previously users had to scan the sensor in order to get a glucose read.  

The way it works is users apply a small sensor, roughly the size of two stacked quarters, on the back of their upper arm. The system will then be able to monitor their glucose levels. The wearable can last for up to 14 days, which the company is pitching as one of the longest-lasting iCGMs. 

Like other versions of the FreeStyle Libre, the system will be able to transmit data to a handheld device where users can view their glucose readings and trends. According to the company, the system is developed to eventually be used with a smartphone device. 

This announcement has been a long time coming. As far back as July of 2019, the company announced its plans to vamp up its manufacturing capacity, in part to clear the way for the U.S. launch of the FreeStyle Libre 2

According to the MedTech device company the system will be rolled out at pharmacies across the US within the next coming weeks. It said it will offer the FreeStyle Libre 2 at the same price point as its predecessor, which came onto the market in 2018.  


Diabetes impacts roughly 34.2 million adults in the United States, according to the CDC. It is associates with kidney failure, lower-limb amputations and adult blindness. 

It can also be a finical burden on the health system and the patients, with costs associated with the condition totaling at approximately $327 billion a year, according to the American Diabetes Association. The company is pitching this as an easier way to manage the condition at a less expensive price point. 

"Managing diabetes is expensive, even for those with insurance coverage," Jared Watkin, senior vice president for Diabetes Care at Abbott, said in a statement. "From the start, Abbott designed FreeStyle Libre technology with affordability in mind. We set a global price for our sensing technology that's closer to that of traditional blood glucose fingerstick systems, and significantly less than other CGMs, because we wanted to make sure our life-changing technology was accessible to as many people as possible."


In 2017 Abbott’s Freestyle Libre system became the first CGM to be FDA cleared for use without fingersticks. At the time the system was cleared for 10-day use, but in 2018 Abbott got another clearance for its FreeStyle Libre 14 Day Flash Glucose Monitoring System

Just last week a new study published in US Endocrinology found Abbott’s continuous glucose monitoring system, the FreeStyle Libre, demonstrated significant cost savings for diabetic care compared to traditional fingerstick testing. 

Abbott isn’t the only major CGM maker in the U.S. Dexcom and Medtronic are among the other big names in the industry. Just this week, rival company Dexcom announced that its G6 Pro would begin shipping in July. Among other features, the G6 Pro allows for blinded and unblinded modes of use, and can read glucose values up to every five minutes. Like the FreeStyle Libre 2, it is also cleared to be used without the need for fingerstick calibrations. 


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