Article text follows link:

 

FDA clears the first iPhone app for delivering insulin, rollout starts this 
spring

Chance Miller

- Feb. 17th 2022 8:44 am PT

@ChanceHMiller

from: 
https://9to5mac.com/2022/02/17/fda-clears-the-first-iphone-app-for-delivering-insulin-rollout-starts-this-spring/

 

The Food and Drug Administration has cleared what is described as the 
first-ever smartphone application capable of initiating insulin delivery on 
both iOS and Android operating systems. The system here comes from Tandem 
Diabetes Care, and the application ties in to the company’s t:slim X2 insulin 
pump.

 

Prior to this approval from the FDA, delivery of insulin had to be handed 
through the pump itself. This change, however, means that users will be able to 
“program or cancel bolus doses of insulin” using the app for iPhone and Android 
devices, according to The Verge. Previously, the app could be used for 
monitoring trends and historical data, but not for initiating the delivery of 
insulin.

 

            “This FDA clearance further validates our commitment to innovation 
and the diabetes community by providing one of the most requested feature 
enhancements,” said John Sheridan, president and CEO of Tandem Diabetes Care. 
“With the improvements in diabetes management provided by Tandem’s Control-IQ 
technology, giving a meal bolus is now the most common reason a person 
interacts with their pump, and the ability to do so using a smartphone app 
offers a convenient and discrete solution.”

 

Tandem Diabetes Care says that it will make this feature available to existing 
users at no additional cost. The feature will begin rolling out this spring 
with a series of “limited launch groups,” with a full launch later in the 
summer.

 

            When released, this new feature will be offered in the United 
States for no additional cost to new t:slim X2 insulin pump customers and to 
in-warranty customers through a remote software update for the t:slim X2 
insulin pump and the updated t:connect mobile app. The Company intends to roll 
out the mobile bolus feature update throughout the spring in a series of 
limited launch groups, followed by an expanded launch later this summer. 
Limited launch participants have already been selected.

 

This approval from the Food and Drug Administration comes as Apple itself is 
said to be investigating potential diabetes treatment technology for the Apple 
Watch. While Apple’s roadmap in this area is ambitious, more recent reports 
have said that the company has hit multiple roadblocks. One report in 2017 
indicated that Tim Cook had been seen actively wearing a glucose tracker 
prototype on his body around Apple’s campus. 

 

You can learn more about today’s announcement in Tandem Diabetes Care’s full 
press release right here: 

https://redirect.viglink.com/?format=go&jsonp=vglnk_164563539254310&key=c1c7d488bb2df8a8b659d5d41634d304&libId=kzzspcqg010023dg000DLp7uaifyz8oek&loc=https%3A%2F%2F9to5mac.com%2F2022%2F02%2F17%2Ffda-clears-the-first-iphone-app-for-delivering-insulin-rollout-starts-this-spring%2F&v=1&out=https%3A%2F%2Finvestor.tandemdiabetes.com%2Fnews-releases%2Fnews-release-details%2Ftandem-diabetes-care-announces-fda-clearance-tslim-x2-insulin-0&title=FDA%20clears%20the%20first%20iPhone%20app%20for%20delivering%20insulin%2C%20rollout%20starts%20this%20spring%20-%209to5Mac&txt=full%20press%20release%20right%20here.

 

 

 

Richard

 

 

My web site; https://www.turner42.com/

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