The Freestyle Libre Pro is able to collect up to 14 days worth of continuous glucose results to help doctors better evaluate how people are managing their diabetes. The good news of the approval comes amid Abbott's continued legal dispute with diagnostics company Alere.
FDA has approved Abbott Laboratories's hotly anticipated Freestyle Libre Pro continuous glucose monitoring system, Abbott announced Wednesday.
The Freestyle Libre Pro includes a disposable sensor that is small, round, and waterproof. Placed on the upper arm with an adhesive pad, it is able to collect glucose level data every 15 minutes, providing up to 1340 glucose results for up to 14 days. Glucose is measured in interstitial fluid through a 5-by-0.4-mm filament inserted just under the skin.
After the 14 days, a doctor is able to quickly download the data off the sensor using the FreeStyle Libre Pro reader.
"This novel technology provides a solution to the ongoing challenge of the need for complete and dependable glucose data. This data is imperative for not only the doctor, but also for the patient to help them achieve optimal health," Jared Watkin, senior vice president of diabetes care at Abbott, said in a news release.
Wednesday overall was a big day for diabetes devices: There was also FDA approval of Medtronic's MiniMed 670G artificial pancreas.
The good news out of Abbott comes amid continued legal wrangling with diagnostics company Alere--which has sued in Delaware Chancery Court to complete a $6 billion merger that Abbott executives no longer appear interested in completing. Mediation has failed, and Alere has now scheduled an October 21 shareholders meeting to vote on the deal, according to a new Securities and Exchange Commission filing.
Abbott is also in the process of acquiring St. Jude Medical for $25 billion.
Abbott boasts that the FreeStyle Libre Pro is not only easy to use, but also more affordable because it does away with the need for extra recorders, receivers, and transmitters associated with other continuous glucose monitoring systems. Because it is disposable, there are no reusable components that need recharging or disinfecting. Simply wear the FreeStyle Libre Pro for two weeks and then throw away. The doctor's office only needs one reader for multiple sensors.
"This technology is groundbreaking because continuous glucose monitoring systems for professional use have been long considered a niche, cumbersome, and expensive technology for mostly type 1 patients. The FreeStyle Libre Pro system changes this paradigm not only because of the unique technology but because it doesn't require fingerstick calibration, is easier to use, more affordable, and is more accessible to people with diabetes," Eugene E. Wright Jr., MD, of Duke Southern Regional Area Health Education Center in Fayetteville, NC, said in the Abbott news release.
Abbott already recieved a CE Mark for the FreeStyle Libre Pro in 2014, and it was approved for use in India last year.
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[Image courtesy of Abbott Labs]