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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 announced it received US clearance for its 15-day CGM, which has a MARD of 8.0% and is expected to launch in the second half of 2025 to allow for integration with insulin pumps.

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.

Research Finds Benefit From DME Suppliers For People Living With Diabetes

 
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People living with diabetes who receive continuous glucose monitors (CGMs) through medical supply firms show higher compliance, lower costs of care, and fewer hospitalizations after one year than those who use pharmacies, a new study shows.

Dexcom Faces US FDA Warning Amid Agency Review Of 15-Day Sensor

 
• By Shubham Singh

Even if manufacturing challenges don’t derail the 2025 launch plans, the regulatory setback introduces new challenges for Dexcom’s continuous glucose monitors at a time when competition from Abbott and Medtronic is intensifying.

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