On December 20th, the FDA approved the G5 mobile blood glucose monitoring system produced by Dexcom to expand the use of diabetes in patients over the age of 2, instead of the traditional fingertip test blood glucose to determine the use of insulin. This is the first time the FDA has approved the monitoring of blood glucose through the Continuous Blood Glucose Monitoring (CGM) system without the use of traditional finger prick test blood glucose. Previously, Dexcom's system was only approved for use as a supplement to conventional test methods or as an auxiliary instrument.
Dr. Alberto Gutierrez, Director of the Office of In Vitro Diagnostic and Radiation Health at the FDA's Equipment and Radiation Health Center, said: The FDA has been doing its utmost to study the safety and accuracy of new medical devices for routine disease management use, although Dexcom The G5 mobile blood glucose monitoring system still requires at least two calibrations per day (at least every 12 hours) through the traditional fingertip acupuncture test, but it does give the diabetic patients more comfort during the treatment process. The way to help patients truly do continuous blood glucose monitoring behavior, thus helping doctors and patients to achieve better treatment decisions.
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