RE: [IP] Tandem pump Tandem Receives FDA clearance!
So I just read the d-mine writeup. It talks about recharging the eco-friendly
battery taking 2.5 h via usb. So what am I supposed to do for 2.5 h while I'm
standing next to my computer (and its usb connection) while the thing recharges?
Does this make any sense?
-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of
email @ redacted
Sent: Wednesday, November 16, 2011 3:24 PM
To: email @ redacted
Subject: RE: [IP] Tandem pump Tandem Receives FDA clearance!
More info
http://www.diabetesmine.com/2011/11/newsflash-tandems-sleek-new-tslim-pump-c
lears-fda.html?utm_source=rss&utm_medium=rss&utm_campaign=newsflash-tandems-
sleek-new-tslim-pump-clears-fda
Person who has touched it says its waterproof
-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of John H
Sent: Wednesday, November 16, 2011 1:12 PM
To: email @ redacted
Subject: Re: [IP] Tandem pump Tandem Receives FDA clearance!
Anyone know how waterproof this is. I couldn't find the info on their website.
________________________________
From: Jan Chait <email @ redacted>
To: email @ redacted
Sent: Wednesday, November 16, 2011 1:48 PM
Subject: RE: [IP] Tandem pump Tandem Receives FDA clearance!
WooHOO!!!! I played with one of these at AADE in August and decided that would
be my next pump. My Cozmo warranty expires in December. Just in time!
Thank you, thank you.
Jan and Elvis
-----Original Message-----
From: email @ redacted
[mailto:email @ redacted] On Behalf Of
email @ redacted
Sent: Wednesday, November 16, 2011 1:37 PM
To: email @ redacted
Subject: [IP] Tandem pump Tandem Receives FDA clearance!
Not wanting to distract from the fund raising and lancet change emails that
have dominated the last few weeks.....
I thought this group might be interested in this
Its part of an email I received this morning:
Good Morning,
As you are a person who is passionate about advancing diabetes management, I am
excited to share that Tandem Diabetes Care has received clearance from the FDA
to market its t:slim Insulin Delivery System. This allows us to move forward
with the commercialization of t:slim in early 2012.
The t:slim was designed to be slim, sleek, and easy to use. This milestone of
FDA clearance will allow Tandem the opportunity to offer people this
full-featured insulin pump, which has the first-ever color touch screen.
As part of Tandem's commitment to excellence, during the first half of 2012 we
will be focused on building the Company's customer support, sales, clinical, and
business operations in preparation for launch.
I look forward to providing you with updates as we move closer to bringing the
t:slim to market.
TANDEM DIABETES CARE ANNOUNCES FDA CLEARANCE OF THE T:SLIMT INSULIN DELIVERY
SYSTEM Smallest Insulin Pump System and First-Ever with a Touch Screen
SAN DIEGO, November 16, 2011-Tandem Diabetes Care, Inc. today announced that
the U.S. Food and Drug Administration (FDA) has granted the Company clearance to
market the t:slimT Insulin Delivery System (t:slim). This new full-featured pump
is the first-ever with a color touch screen, and is the smallest insulin pump
system currently available. The t:slim is one of the first insulin pumps to be
cleared under the FDA's new Infusion Pump Improvement Initiative.
"With the clearance of t:slim, Tandem Diabetes Care has an opportunity to set a
new standard in insulin infusion therapy," said Kim Blickenstaff, president and
CEO, Tandem Diabetes Care. "In creating t:slim, we spoke with more than 4,000
healthcare professionals and people with diabetes, and the clear message we
heard was, 'make it cool and make it uncomplicated to use.
Give us access to the most advanced features without extra effort.' The
t:slim's touch screen interface has been proven in extensive user studies to be
easy to learn and to use by new and experienced pump users alike."
Of approximately 1.5 million people in the U.S. with type 1 diabetes,[i]
industry estimates indicate that only 20 to 30 percent use an insulin pump,
despite clinical evidence that pump use can improve glycemic control and quality
of life.[ii] Tandem Diabetes Care believes that enhanced ease of use and
attractive design will encourage more patients to consider the clinical benefits
of insulin pump therapy.
"Medical devices are often designed for the hospital setting, not for everyday
life. Things like size, look, and feel are often overlooked," said Dr. Timothy
Bailey, director of the Advanced Metabolic Care and Research Institute.
"Patients need an insulin pump designed to easily integrate into their daily
lives. The device needs to be unobtrusive and look more like the consumer
electronics they already use every day."
The t:slim has a vivid color touch screen and was designed to make diabetes
management easier to teach and easier to learn. Additional user-oriented
features of this insulin pump include an eco-friendly rechargeable battery and
USB connectivity to a web-based therapy management software.
As part of Tandem Diabetes Care's commitment to excellence, the Company will be
building its customer support, sales, clinical, and business operations in
preparation for U.S. launch during the first half of 2012.
For broadcast quality B-roll footage, please visit:
http://videostorage.prnewswire.com/storage2/download/53296HD.zip
About the t:slim Insulin Delivery System The t:slim is a modern, programmable
insulin infusion pump for people with diabetes mellitus age 12 and greater who
require insulin. The pump's streamlined interface provides users with quick and
easy access to all the device's functions. The t:slim features Tandem's
proprietary micro-delivery technology, which provides safe and accurate insulin
delivery from a 300-unit cartridge, and allows for the device's
slimmest-in-class form factor.
About Tandem Diabetes Care, Inc.
Dedicated to advancing the management of diabetes, Tandem Diabetes Care, Inc.
(www.tandemdiabetes.com) is a privately held company with novel technology and a
comprehensive, user-centric and integrated approach to product development and
customer care. Tandem is based in San Diego, Calif.
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