FDA approves Abbott’s 14-day continuous glucose monitor

The FDA approved the FreeStyle Libre flash glucose monitoring system, which works for up to 14 days at a time, according to a July 27 announcement from device maker Abbott.

The system is now the longest continuous glucose monitor available in the U.S., Abbott said. A 10-day version of the device was approved by the FDA in September.

“At Abbott, we are continuously pushing for new innovations that minimize the daily burden of managing diabetes," Jared Watkin, the company’s senior vice president of Diabetes Care, said in the press release. “With the new FreeStyle Libre 14-day system, people with diabetes will now have extended access to their glucose data with a high degree of accuracy, which will improve their experience and help empower them to better manage their condition.”

The sensor is about the size of two stacked quarters and can be self-applied to the back of the upper arm to provide real-time glucose updates. It eliminates the need for routine finger sticks.

According to the FDA’s approval notice, the FreeStyle Libre system can help detect acute episodes of hyperglycemia or hypoglycemia as well as inform long-term treatment adjustments.   

""

Daniel joined TriMed’s Chicago editorial team in 2017 as a Cardiovascular Business writer. He previously worked as a writer for daily newspapers in North Dakota and Indiana.

Around the web

“Now more than ever, we must recognize that our country’s leadership in groundbreaking medical research spurs scientific innovation, improves public health and creates new innovations that save and improve lives nationwide,” Joseph C. Wu, MD, PhD, explained in a statement. 

The technology used to diagnose, treat and manage cardiovascular disease is always evolving, keeping FDA officials quite busy. But have the agency's standards been slipping in recent years? A cardiologist with Cedars-Sinai Medical Center explored that very question.

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.”