DexCom Glucose Monitoring Systems Progress Toward FDA Approval
This article was originally published in The Gray Sheet
Executive Summary
A recently completed 86-patient study will support DexCom's anticipated PMA application for theSTS seven-day continuous glucose monitoring system
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People In Brief
DexCom adds sales force: San Diego-based startup brings Rodney Kellogg on board as VP-sales in anticipation of impending approval for its continuous glucose monitoring technology. As VP of Smiths Medical's diabetes division, Kellogg was responsible for much of the infrastructure needed to launch the firm's Deltec insulin pump, according to DexCom CEO Andy Rasdal. After receiving expedited review status, DexCom's STS three-day continuous monitoring system hit a snag when FDA issued a "major deficiency" letter requesting more information (1"The Gray Sheet" Aug. 8, 2005, p. 20). The company also has a seven-day system under review...
People In Brief
DexCom adds sales force: San Diego-based startup brings Rodney Kellogg on board as VP-sales in anticipation of impending approval for its continuous glucose monitoring technology. As VP of Smiths Medical's diabetes division, Kellogg was responsible for much of the infrastructure needed to launch the firm's Deltec insulin pump, according to DexCom CEO Andy Rasdal. After receiving expedited review status, DexCom's STS three-day continuous monitoring system hit a snag when FDA issued a "major deficiency" letter requesting more information (1"The Gray Sheet" Aug. 8, 2005, p. 20). The company also has a seven-day system under review...
Abbott takes DexCom to court
Patent infringement complaint filed by Abbott in a Delaware district court alleges that DexCom's continuous glucose monitor system is derived from Abbott's patents. Both DexCom (STS) and Abbott (Freestyle Navigator) are vying to reach the U.S. market. DexCom responds that since neither product is commercialized, the firm is "not harming Abbott's current glucose monitoring business in any manner" and that Abbott could not have been able to scientifically investigate the STS. DexCom filed for PMA approval in March (1"The Gray Sheet" Aug. 8, 2005, p. 20)...