FDA OKs Abbott's glucose monitoring system

The US Food and Drug Administration has approved health care major Abbott Laboratories' FreeStyle Navigator continuous glucose monitoring system for people with diabetes. Designed to discretely and continuously measure glucose levels through a sensor in the back of the upper arm or abdomen, the system provides minute-by-minute information about which way and how quickly blood sugar levels are changing. This information can lead to proactive adjustments that can result in tighter glucose ranges. Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator system, traditional blood glucose tests must be performed.

The FreeStyle Navigator system will be available in the second quarter of 2008 by prescription only. It received CE Mark approval in June 2007 and has been available outside the USA since September last year, the firm noted.