Dexcom introduced final week that its G7 steady glucose monitoring system has obtained FDA clearance.
The most recent mannequin of its CGM, which can be utilized by individuals with all sorts of diabetes ages 2 and up, is anticipated to launch within the U.S. early subsequent yr. As the corporate works out insurance coverage protection for the G7, it plans to supply money fee choices for early adopters.
The CGM suits on the again of the higher arm, or the higher buttocks for pediatric sufferers if they like, and sends glucose readings to a appropriate sensible gadget or a Dexcom receiver.
Dexcom touts a 30-minute sensor warmup for the G7, which it compares to an hour or longer for competing CGM manufacturers. It additionally gives customizable alerts for top or low glucose and a predictive alert that may provide a 20-minute warning forward of probably harmful low blood glucose ranges.
The corporate mentioned it’s working with insulin pump suppliers to combine the G7 into present and upcoming automated supply techniques.
“After we got down to design G7, our aim was easy: to take advantage of highly effective, easy-to-use CGM out there for individuals with diabetes, whether or not they have Sort 1 or Sort 2. G7 delivers squarely on that promise. And now that it has been cleared by the FDA, we look ahead to making G7 commercially out there within the coming months,” Kevin Sayer, chairman, president and CEO of Dexcom, mentioned in an announcement.
THE LARGER TREND
Dexcom first submitted for regulatory clearance within the fourth quarter final yr. The G7’s launch was delayed after the FDA got here again with questions concerning the gadget throughout its evaluation, prompting a software program replace. The G7 obtained a European CE Mark in March this yr.
The earlier mannequin of Dexcom’s CGM, the G6, obtained the FDA inexperienced mild in 2018. On the time, the FDA mentioned the G6 was the primary system that may very well be used with different appropriate medical units and digital interfaces, like automated insulin dosing techniques, insulin pumps and blood glucose meters.
“Along with being interoperable and connectable, we have additionally enhanced cybersecurity right here,” Sayer informed MobiHealthNews in January. “We actually have taken new know-how. Our circuit and chip within the G6 was developed manner again within the 2016-17 timeframe, and cybersecurity and Bluetooth has superior considerably since then. So the brand new chips now we have on this will once more make individuals really feel safer.”
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