A Medical Device Daily

The FDA has approved the FreeStyle Navigator continuous glucose monitoring system (GCM), made by Abbott (Abbott Park, Illinois).

Designed to continuously measure glucose levels through a sensor placed in the back of the upper arm or abdomen, FreeStyle provides minute-by-minute information about which way and how quickly blood sugar levels are changing, enabling quick adjustments in tighter glucose ranges, Abbott said.

The FreeStyle is composed of a sensor, a transmitter and a receiver. The sensor, worn for up to five days and then replaced, is placed just under the skin and attached to a plastic sensor mount with adhesive to adhere to the skin, like a patch. The transmitter snaps into the sensor mount and sends glucose information wirelessly to the pager-sized receiver.

Richard Bergenstal, MD, endocrinologist and director of the international diabetes center, said that a continuous glucose reading puts patients with diabetes “We are always looking for new tools like these to enable people with diabetes “on the offense, not defense, so they can take action before a high or low glucose level occurs.”

Larry Biegelsen, medical technology analyst at Wachovia Securities, issued a note saying that the Navigator “is the third CGM device to be approved in the U.S. after Dexcom’s and Medtronic’s. Abbott expects Navigator to be available in the U.S. in 2Q08. Last year, we had heard that Abbott was considering terminating the development of Navigator after running into approval delays, but obviously this turned out to be false.”