I think this an indicator of level of confidence that FDA Clearance is forthcoming.
Given my experience with FDA (from a tech perspective not from a drug perspective) this will get clearance I think it would be the fact that it relies on a smart phone that is the point of concern. i know that this has held up other products as well.
Here is what they emailed me.
At the moment we do not offer interfaces to pumps, yet we are well aware of this need an may introduce this feature in the future.
Customer Support Manager
(What's up with the BH?)
Actually, to get to the moon we will need a few milestones.
First : FDA Clearance
Second : Insurance coverage
Third : the test strips to be considered as preferred formulary for diabetics that order three month supplies at a discounted rate.
Then we need the app to have API's into other devices such as the Dexcom for automatic calibration and insulin pumps so that the glucose levels do not have to be manually entered. This will give them an advantage over the big boys like J&J (one touch/Life Scan) etc...
Doc, i don't know your background, but as a dexcom user (I have no stake in the company) I believe you're mistaken. first they actually have a brilliant business model the Animas pump from J&J is integrated with the Dexcom, the Omni Pod is working on it, where both the dexcom and pods will be controlled by smart phone. T:Slim by Tandem is awaiting FDA Clearance on their integrated G4 puump. accuracy of the g4 surpasses the medtronics cgm. many times I check the dexcom then take a blood test and the numbers are the same! They set themselves up that any pump company can develop an integrated pump as long as they conform to the dexcom standard, which means they will set the standard since they are not competing with the pump manufacturers.
and by the way, I can set you up with a synagogue that offers free crash courses in hebrew.
send me a private message to my profile and I'll be glad to help you out.
Basically if clearance is given for this device to be sold here in the US, it should be reasonable to see a price increase to about $3 or 10x of current trading price.
The point I was making is that there seems to be a bit of confusion between FDA approval and FDA Clearance approval is only for drugs and new therapies, whereas clearance is for medical devices that are new but are to be used for a known purpose. So a new glucose monitor only needs clearance not approval.
this is a much shorter process, since they only need to prove that their device works in line with established standards.
I've used a number of insulin pumps, this is the best one out there to date. also the coolest machines that the kids will be comfortable with. This is since it has a similar interface to an iPhone. no other pump is even close to the coolness factor as the T:slim.
No, ECTE is just pie in the sky with nothing to show for their efforts.
I use a Dexcom (I've got LADA Diabetes) and think it's great. it has nothing to do with not pricking a finger because you still need to do that.
Rather, I and many others can't feel their sugar dropping to dangerous levels until it is too late. The Dexcom provides me with early notification and has kept me out of the ER
I think you are a bit confused, an injection is used for insulin, a lancet to #$%$ a finger is for glucose testing, the Dexcom requires that you inject a new wire under your skin every week. it does not just sit on top of your skin.
Yes I did notice that and always ignore them all. Once upon a time intelligent conversations happened here on these boards, but that is long past gone.