SAN DIEGO – The U.S. Food and Drug Administration has granted approval for DexCom’s G6 continuous glucose monitoring system for people with diabetes. The system was granted a De Novo request for use as both a standalone CGM and for integration into automated insulin dosing systems. Along with this authorization, the FDA is establishing special controls that outline requirements for assuring CGM accuracy, reliability and clinical relevance, as well as describe the type of studies and data required to demonstrate acceptable CGM performance. “The FDA’s special controls set a rigorous new standard in our industry and clearly define the process by which other CGM systems may be approved,” said Kevin Sayer, CEO ofcDexcom, in a statement. “We believe the new Dexcom G6 is a significant step forward for our industry.” The Dexcom G6 has new features, including: no fingersticks; easy sensor applicator; low profile; acetaminophen blocking; 10-day sensor; and predictive hypoglycemia alert. Dexom plans to launch the system later this year.
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