December 16, 2019
The FDA announced Friday a De Novo clearance for an interoperable automated glycemic controller device for use in a hybrid closed-loop diabetes management system.
Tandem Diabetes Care’s Control-IQ Technology acts as a new feature for the company’s t:slim X2 insulin pump (which was also cleared by the FDA back in February). The controller algorithm allows the pump and its connected system to...
February 19, 2019
Last week the FDA granted its first marketing authorization to an interoperable insulin pump that is compatible with automated insulin dosing systems, continuous glucose monitors, blood glucose meters and other diabetes therapy devices built by different manufacturers.
The Tandem Diabetes Care t:Slim X2 insulin pump was reviewed through the De Novo premarket review pathway, making it the first of...
August 15, 2017
Touchscreen insulin pump maker Tandem Diabetes announced a new clinical trial for an insulin pump with a predictive low glucose suspend (PLGS) algorithm. Another step on the road to an artificial pancreas, PLGS allows Tandem to automatically suspend insulin delivery when it predicts low glucose and resume it when glucose starts to rise again.
“The start of this pivotal trial is another important...
April 11, 2017
VR-neurostimulation combo device gets crowdfunded. While there has been plenty of buzz about virtual reality technology in clinical settings, it seems there is consumer demand health-focused VR as well. Kortex, a new wearable from medical device company Fisher Wallace Labs, uses a combination of the neurostimulation and VR to improve sleep quality and stress management. The device, which is built...
March 2, 2017
Tandem Diabetes Care, maker of a touchscreen insulin pump, has launched their first remote software update. Users of the t:slim Insulin Pump (purchased before 2015) will be able to use their personal computer to update their device. The Tandem Device Updater will eventually facilitate updates as there are approved by the FDA, such as those that allow integration between devices.
Age is more...
February 17, 2017
In a head-to-head comparison of sensor-augmented insulin pumps, the touchscreen device from Tandem Diabetes Care outperformed that from Medtronic, according to new data presented at the Annual Advanced Technologies and Treatments for Diabetes conference in Paris.
The self-reported data from San Diego-based Tandem comes from a retrospective study analyzing de-identified data from 3,046 Tandem SAP...
November 10, 2016
A new clinical trial to investigate the use of artificial pancreas system is set to begin, bringing in touchscreen insulin pump maker Tandem Diabetes Care; Dexcom, which makes continuous glucose monitor; and digital, personalized medicine company TypeZero Technologies.
The International Diabetes Closed Loop trial, funded by a grant from the National Institutes of Health to the University of...
June 16, 2014
The Dexcom G4 was the continuous glucose monitor used in the study.
An artificial pancreas system -- consisting of a continuous glucose monitor, and insulin pump, and an iPhone 4s -- has been shown to improve glucose regulation in a simulated outpatient setting in both adults and adolescents with Type 1 diabetes, according to a new paper in the New England Journal of Medicine. The adult...