Tag: CGM

New Dexcom G4 PLATINUM Approved by FDA

The U.S. FDA has approved Dexcom's new continuous glucose monitoring system, the Dexcom G4™ PLATINUM. According to clinical trials the new Dexcom G4 PLATINUM has much improved accuracy with up to approximately 19 percent improvement in overall accuracy for the Dexcom G4 PLATINUM compared to the Seven Plus, and approximately a 30 percent improvement in accuracy in the hypoglycemia range. The overall accuracy and ease of use for the Dexcom G4 PLATINUM sets a new standard for commercially available CGMs, making the Dexcom G4 PLATINUM the most-advanced CGM system available.
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Positive Results for Echo Therapeutics’ Transdermal Continuous Glucose Monitoring System

Echo Therapeutics announced positive results from its clinical trial of the Symphony tCGM System, a non-invasive, wireless, transdermal continuous glucose monitoring system, in major general surgery and cardiothoracic surgery patients. This study is the second of two studies in critically ill patients. Data from this study demonstrate that Symphony successfully and continuously monitored glucose levels in the intensive care unit at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania.
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Medtronic’s Enlite Sensor: The Waiting is the Hardest Part

First, the new Enlite sensor — and I really should use “new” in quotation marks because it has been available in Europe for about a year — is much more comfortable and accurate than previous Minimed sensors. Second, the Veo pump itself has a glucose suspend feature, meaning that if the Enlite sensor detects your blood glucose is below 70, it can stop insulin delivery on its own.
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Medtronic Launches mySentry the First-Of-Its-Kind Remote Glucose Monitor

Medtronic announced the U.S. market launch of the first-of-its-kind mySentry™ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm® REAL-Time Revel™ System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide...
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Medtronic Launches mySentry the First-Of-Its-Kind Remote Glucose Monitor

Medtronic announced the U.S. market launch of the first-of-its-kind mySentry™ Remote Glucose Monitor, which allows a parent or caregiver to monitor from another room a patient’s MiniMed Paradigm® REAL-Time Revel™ System. The remote glucose monitor also marks the launch of a new category of Connected Care solutions that will provide...
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FDA Grants Medtronic Approval to Conduct In-Home Study of Insulin Pump with Low Glucose Suspend

The U.S. Food and Drug Administration (FDA) has given Medtronic approval of its Investigational Device Exemption (IDE) to conduct a pivotal in-home clinical trial protocol for the ASPIRE (Automation to Simulate Pancreatic InsulinREsponse) study of the MiniMed Paradigm® System featuring Low Glucose Suspend (LGS) automation. FDA approval of the IDE makes Medtronic’s ASPIRE study the first in-home pivotal trial of a closed loop system for type 1 diabetes management...
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