FDA stall on diabetes device cost Abbott

CHICAGO, Nov. 26 (UPI) -- Regulatory delays have prevented Abbot Laboratories' real-time glucose monitor from reaching the U.S. market.

The company's "FreeStyle Navigator" is a pager-like device that constantly monitors diabetics' blood sugar levels. The monitor was initially touted as a potential $1 billion blockbuster, but the delay in reaching the market could make profits fall far short of expectations, Crain's Chicago Business reported Sunday.

A Food and Drug Administration review has been stalled for two years, and though approval is expected in the next few weeks, earnings estimates have been revised to $500 million or less.

Original estimates of the device's earning power were based on the possibility it would be the first to reach the market, but last year San Diego-based DexCom Inc. introduced its own real-time glucose monitor. Since then Medtronic Inc., a Minnesota-based medical device giant, also introduced a similar device.

Analysts are divided on the device's earning prospects, Crain's said. While some say even $500 million is an optimistic figure, others say the Navigator could earn as much as $800 million by 2010 if insurers choose to cover it.