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Tandem Wins FDA Clearance On First Stand-Alone Glycemic Controller

 
• By Elizabeth Orr and Marion Webb

Tandem Diabetes Care received FDA clearance for its Control-IQ technology for use with Tandem's t:slim X2 insulin pump and Dexcom's G6 continuous glucose monitoring system, making it the first hybrid closed-loop system to deliver automatic correction boluses and adjust background insulin levels to help prevent high and low blood sugars.

T slim
Tandem's t:slim X2 insulin pump with Control-IQ technology is the first stand-alone insulin delivery device to win clearance from the US FDA. • Source: Courtesy Tandem Diabetes Care

An automated insulin delivery system that landed marketing authorization from the US Food and Drug Administration on 13 December represents a breakthrough for patients with type 1 diabetes.

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Dexcom’s FDA Warning Letter Shows Risks Of Driving Margin As Firm Aims To Launch 15-Day Sensor

 
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After switching production of coatings for its continuous glucose monitors in-house to improve supply, Dexcom ran afoul of US FDA for failing to submit a premarket notification. Firm says launch of 15-day sensor will not be delayed by the problems.

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