Abbott (NYSE:ABT) said today it won CE Mark approval in the European Union for its FreeStyle Libre flash glucose monitoring system for patients aged 4-17.
The FreeStyle Libre flash is designed to monitor glucose through a sensor worn on the back of the upper arm for 2 weeks, without the need for the finger prick calibration required by continuous glucose monitoring systems, Abbott said.
“Children and teens with diabetes and their families have to navigate many challenges in their daily lives as they care for this complex condition. The scientists and engineers at Abbott have made it their life’s work to provide the most innovative technology to help people with diabetes improve their diabetes management and ultimately, live happier and healthier lives,” diabetes care senior veep Jared Watkin said in a prepared statement.
Data from a study of the device indicated that the FreeStyle Libre flash was accurate, stable and consistent for up to 14 days without finger prick calibration amongst patients aged 4 to 17, Abbott said. A total 97% of the children and teens in the study reported that the system was easier to use than finger prick systems as well.
“The availability of FreeStyle Libre for children is a critical milestone for children living with diabetes. The technology in Abbott’s FreeStyle Libre is transformative because it changes how self-monitoring has been done for decades—and is proven to be accurate and stable. I look forward to seeing my young patients achieve better diabetes management, while giving their parents and caretakers more peace of mind,” Dr. Emanuele Bosi of Milan, Italy’s San Raffaele Hospital said in prepared remarks.
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