Tandem ’s New Clearance Strengthens Relationship with DexCom

Tandem Diabetes has won a major nod from FDA that has the potential to advance its partnership with DexCom. The San Diego, CA-based company received clearance for the t:slim X2 insulin pump with Control-IQ technology, which integrates with Dexcom G6 continuous glucose monitoring (CGM) sensor. The technology uses the DexCom G6 CGM sensor values to forecast glucose levels and adjust insulin delivery to ensure the prevention of erratic highs and lows. San Diego, CA-based DexCom’s CGM requires no fingersticks for calibration or diabetes treatment decisions. Tandem first won FDA approval for the t:slim X2 insulin pump earlier this year. The approval was significant because it created a new device category – Alternate Controller Enabled Infusion Pumps. The Control-IQ technology for the t:slim X2 insulin pump is an automated insulin dosing software in a new interoperable automated glycemic controller category that automatically adjusts insulin delivery to a person with diabetes by connecting to an alternate controller-enabled insulin pump (ACE pump) and integrated continuous glucose monitor (iCGM). “Approval of the Control-IQ system with Dexcom G6 CGM brings together two incredible products to deliver a powerful automated insulin dosing solution for people with diabetes,” Kevin Sayer, president and CEO of Dexcom, said in a release. “Sensor accuracy is a critical component for automated insulin ...
Source: MDDI - Category: Medical Devices Authors: Tags: Digital Health Source Type: news