Abbott Wins Nod for 14 Day Version of Freestyle Libre

Abbott Laboratories has received FDA approval of the Freestyle Libre 14 Day Flash Glucose Monitoring System (CGM). FDA’s nod of the Abbott, IL-based company’s device follows on the heels of the 2017 approval of the 10 Day Freestyle Libre CGM in the U.S. The Freestyle Libre 14 day system has a 1-hour warmup and greater accuracy compared to the FreeStyle Libre system (10 day) with a mean absolute relative difference (MARD) of 9.4 compared to 9.7, respectively.  To expand the sensor’s time, Abbott made a slight change in the algorithm. “Instead of three sensors every month its two sensors every month that people need to wear,” Chris Thomas, director of biosensor technology for Abbott, told MD+DI. “Our whole goal is to continuously improve Freestyle Libre so that it seamlessly blends into your life and it makes life easier for people with diabetes.” Through just a one-second scan, users can see real-time glucose readings, as well as identify glucose trends with a directional arrow and review eight hours of glucose history. The sensor is worn on the back of the upper arm and is the size of two stacked quarters. The Freestyle Libre system is supported by both clinical data and real-world evidence that show that people who scan more frequently spend less time in hypoglycemia (low-glucose levels) or hyperglycemia (high-glucose levels) w...
Source: MDDI - Category: Medical Devices Authors: Tags: Business Source Type: news