FDA Approves Prickless Glucose Monitoring System

The U.S. Food and Drug Administration has announced approval of Abbott’s FreeStyle Libre flash glucose monitoring system for certain diabetes patients.  The glucose monitoring tool will allow patients to monitor their glucose levels the without painful and inconvenient finger pricks of traditional glucose monitoring.

According to an Abbott press release, the FreeStyle Libre system will allow patients to self-apply the sensor (which is about the size of two stacked quarters) to the back of the upper arm and capture real-time glucose readings with painless scans of a small hand-held reader over the scanner.  This is in contrast to traditional blood glucose monitoring, which may require some patients to finger stick up to 12 times per day.

According to the Centers for Disease Control and Prevention, over 29 million Americans have diabetes.  The FreeStyle Libre system, which became available by prescription from most retail pharmacies in the U.S. by the end of 2017, should enable patients to better manage their disease.  Healthline reports that the product has been available for several to patients in other areas of the world.  Dr. Maria Tulpan of Lenox Hill Hospital in New York, NY commented:

What we see with the FreeStyle Libre system is patients gaining a better understanding of the impact of food, exercise and specific medications on their glucose levels due to availability of the data, which is important in the day-to-day management of diabetes and for behavioral changes towards improved diabetes control.

Abbott states that the FreeStyle Libre Flash Glucose Monitoring System is based on proprietary technology and lists over 50 U.S. Patents issued to Abbott Diabetes Care, Inc., that is believes are associated with the device.  Representative examples include U.S. Patent Nos. 8,889,305, 9,000,929, and 9,014,774.

Mark Rubinshtein
Mark Rubinshtein's practice focuses on patent litigation and prosecution for clients in the chemical and pharmaceuticals industries. Dr. Rubinshtein earned his J.D. at University San Diego School of Law. Prior to law school, Dr. Rubinshtein obtained a B.A in Chemistry and M.S. in chemical engineering from Columbia University and completed his PhD in organic chemistry in 2011 at UC San Diego. His graduate work focused on developing targeted small molecular therapeutics for Alzheimer's disease and on devising synthetic methods for the preparation of side-chain functionalized biodegradable and biocompatible polymers.
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