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FDA Clears Reader for Abbott’s Freestyle Libre 3 System

FSL3 SensorReader 112mg EN_Hero Abbott announced that the U.S. Food and Drug Administration (FDA) has cleared a reader for its FreeStyle Libre® 3 integrated continuous glucose monitoring (iCGM) system, which features the world’s smallest, thinnest, and most discreet glucose sensor. With the FDA’s clearance of a standalone reader, Abbott is working to get the FreeStyle Libre 3 system added to Medicare’s...
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Glytec Announces Next Evolution of GlucoMetrics as Hospitals Prepare for New CMS Measures

Glytec today announced the next evolution of GlucoMetricsⓇ to provide new analytics, dashboards, and data visualizations that give hospitals and health systems new insight into glycemic outcomes. The enhanced visibility comes as hospitals prepare for new measures from the Centers for Medicare and Medicaid Services (CMS) on severe hypoglycemia and hyperglycemia that encourage facilities to report metrics starting...
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Bigfoot Biomedical Receives FDA Clearance for Bigfoot Unity® Android App for People Living with Insulin-Requiring Diabetes

Bigfoot Biomedical today announced the U.S. Food and Drug Administration (FDA) has issued 510(k) clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group...