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Abbott continuous glucose monitor gets FDA go-ahead

This article was originally published in The Gray Sheet

Executive Summary

Long-awaited PMA approval of Abbott's FreeStyle Navigator sets the stage for a second quarter launch of the device, the company says. Abbott is the third firm to gain FDA approval for a CGM system after Medtronic (Guardian and Paradigm Real-Time systems) and DexCom (Seven). Navigator, approved March 12, consists of a sensor inserted just under the skin of the arm or abdomen, which can be worn for five days, and a pager-sized receiver that displays glucose information every minute and triggers an audible or vibrating alarm if glucose levels become too high or low. DexCom's sensor can be worn for seven days, and Medtronic's for three. Navigator has a longer 10-hour start-up initialization time versus two hours for the other systems. The market uptake of CGM devices, which are used as adjuncts to finger stick testing, has been slower than anticipated largely due to poor reimbursement, according to analysts (1"The Gray Sheet" Nov. 26, 2007, p. 6)

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